Органосохраняющая протезирующая реконструкция тазового дна вагинальным доступом при передне-апикальном пролапсе (клинико-экспериментальное исследование) тема диссертации и автореферата по ВАК РФ 14.01.01, кандидат наук Шаповалова Екатерина Андреевна

• Шаповалова Екатерина Андреевна
• кандидат наук
• 2019

Оглавление диссертации кандидат наук Шаповалова Екатерина Андреевна

ВВЕДЕНИЕ

Глава 1. ПРОЛАПС ОРГАНОВ МАЛОГО ТАЗА - СОВРЕМЕННОЕ СОСТОЯНИЕ ПРОБЛЕМЫ (обзор литературы)

1.1. Эпидемиология и социально-экономическое значение пролапса тазовых органов

1.2. Современное представление о патогенезе передне-апикального пролапса гениталий

1.3. Эволюция технологий лечения передне-апикального пролапса

1.4. Шовные материалы для аппроксимации структур эндопельвикальной фасции

1.5. Эффективность и безопасность органоуносящих методик лечения передне-апикального пролапса

Глава 2. МАТЕРИАЛЫ И МЕТОДЫ ИССЛЕДОВАНИЙ

2.1. Материалы и методы экспериментального исследования

2.1.1. Исследование in vitro механических свойств шовного материала

2.1.2. Исследование in vivo

2.1.2.1. Механических свойств шовного материла

2.1.2.2. Биомеханических свойств сформированного рубца

2.1.2.3. Гистологических характеристик рубцовой ткани

2.2. Материалы и методы клинического исследования

2.2.1. Общая характеристика пациентов

2.2.2. Предоперационное обследование пациентов

2.2.3. Наблюдение за пациентами в послеоперационном периоде

2.3. Методы статистической обработки полученных данных

Глава 3. РЕЗУЛЬТАТЫ ЭКСПЕРИМЕНТАЛЬНОГО ИССЛЕДОВАНИЯ

3.1. Механические характеристики изучаемых образцов шовного материала в опыте in vitro

3.2. Результаты исследования in vivo

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3.2.1. Макроскопическая оценка шовного материала и послеоперационных рубцов

3.2.2. Механические характеристики изучаемых образцов шовного материала in vivo

3.2.3. Биомеханические характеристики рубцовой ткани, полученной с использованием образцов шовного материала

3.2.4. Особенности реакции тканей животного на различные типы шовного материала

Глава 4. РЕЗУЛЬТАТЫ ОПЕРАТИВНОГО ЛЕЧЕНИЯ ПЕРЕДНЕ-АПИКАЛЬНОГО ПРОЛАПСА ВАГИНАЛЬНЫМ ДОСТУПОМ С ИСПОЛЬЗОВАНИЕМ СИНТЕТИЧЕСКИХ СЕТЧАТЫХ ЭНДОПРОТЕЗОВ

4.1. Результаты лечения пациенток с передне-апикальным пролапсом с использованием полноразмерного имплантата «Пелвикс Передний»

4.1.1. Методика оперативного вмешательства

4.1.2. Результаты лечения пациенток с использованием эндопротеза «Пелвикс Передний»

4.2. Результаты лечения пациенток с передне-апикальным пролапсом путем гибридной хирургической реконструкции тазового дна

4.2.1. Методика оперативного вмешательства

4.2.2. Результаты лечения пациенток с использованием техники гибридной реконструкции тазового дна

4.3. Сравнение эффективности лечения пациенток с передне-апикальным пролапсом в двух группах

ЗАКЛЮЧЕНИЕ

ВЫВОДЫ

ПРАКТИЧЕСКИЕ РЕКОМЕНДАЦИИ

ПЕРЕЧЕНЬ УСЛОВНЫХСОКРАЩЕНИЙ

СПИСОК ЛИТЕРАТУРЫ

ВВЕДЕНИЕ

Введение диссертации (часть автореферата) на тему «Органосохраняющая протезирующая реконструкция тазового дна вагинальным доступом при передне-апикальном пролапсе (клинико-экспериментальное исследование)»

Актуальность исследования

Пролапс тазовых органов (ПТО) является одной из наиболее часто встречающихся гинекологических патологий у женщин среднего и пожилого возраста. ПТО выявляется у 15-30% женщин, достигая 40% в возрастной группе старше 50 лет (Краснопольский В.И., с соавт., 2010; Коршунов М.Ю., 2017). Генитальный пролапс крайне редко является причиной жизнеугрожающих состояний, но он приводит к функциональным расстройствам мочевого пузыря и прямой кишки, снижает качество жизни пациенток и ограничивает круг их повседневных занятий, способствуя социальной дезадаптации (Радзинский В.Е. с соавт., 2008; Русина Е.И., 2018; Jelovsek J.E. et al., 2007; Fritel X. et al., 2009; Mao M. et al., 2018).

Среди различных форм ПТО доминирующее положение занимает опущение передней стенки влагалища, цистоцеле, наблюдаемое у каждой третьей женщины (Hendrix S.L. et al., 2002). Уже в конце 19 века были предприняты первые попытки его хирургической коррекции, которые заключались в иссечении избыточного объема тканей слизистой и последующей их пликации (Sims J.M., 1866). Описанная техника имела множество вариантов исполнения, получив название «кольпоррафия», однако проблема отсутствия стандартизации методики, отмеченная в 90-х годах 20 века, сохраняется и по сей день (Weber A., Walters M., 1997; Harpen-Elenskaia K. et al., 2018). Важное значение в данном виде пластики имеет шовный материал, противостоящий нагрузке внутрибрюшного давления до момента формирования прочного рубца (Petros P.E.P., 1998). Однако на сегодняшний день выбор шовного материала продолжает основывается лишь на индивидуальных предпочтениях хирурга (Bergman I. et al., 2016; Harpen-Elenskaia K. et al., 2018).

Эффективность передней кольпоррафии, по данным исследований, находится в широких пределах: от 70,0% до 97,3% (Porges RF, Smilen SW., 1994; Weber A.M., с соавт., 2001). Причиной низкой эффективность данного вмешательства

может выступать отсутствие симультанного восстановления апикального уровня поддержки, что приводит к рецидиву у 58% пациенток уже через год после операции (Kenton K. et al., 1999). Тесная взаимосвязь между I и II уровнями поддержки (по DeLancey) указывает на целесообразность выделения передне-апикальной формы пролапса, требующей соответствующей двухуровневой реконструкции (Summer A. et al., 2006; Lowder J.L. et al., 2008; Elliot C.S. et al., 2013).

Связь цистоцеле и утероцеле отразилась в исторически сложившемся представлении о необходимости удаления матки, гистерэктомии, для устранения ПТО (Baerj L. et al., 1937; Arthure H. G. E., Savage D., 1957). Несмотря на то, что данный объем оперативного вмешательства не является патогенетически обоснованным, по сей день гистерэктомия остается одной из наиболее популярных операций по поводу опущения органов малого таза (Whiteman M. K. et al., 2008). При этом гистерэктомия, произведенная по поводу ПТО, приводит к развитию постгистерэктомического пролапса в 0,2-45,0% случаев (Flynn B.J., Webster G.D., 2002; Dâllenbach P. et al., 2008; Nyyssonen V. et al., 2013). Необходимо отметить, что и сами женщины зачастую не готовы расстаться с маткой при отсутствии жизненных показаний к этому вмешательству (Neuman M., Lavy Y., 2007; Korbly N.B. et al., 2013; Meriwether K. V. et al., 2018).

Говоря о восстановлении апикального уровня поддержки (I, по DeLancey), среди наиболее распространенных методик выделяют сакрокольпопексию, выполняемую абдоминальным доступом, и крестцово-остистую фиксацию, осуществляемую влагалищным путем. Эффективность обеих операций, согласно ряду исследований, достигает 90-96%, однако данные вмешательства имеют ряд специфических осложнений (Hefni M.A., El-Toukhy T.A., 2006; Sarlos D. et al., 2008; Ganatra A.M. et al., 2009; Meuman N. et al., 2014). Так, выполнение сакрокольпопексии может осложняться выраженной кровопотерей в 4,4% случаев, а в послеоперационном периоде приводить к развитию у 4,7-50,0% пациенток обструктивной дефекации (Nygaard I.E. et al.,2004; Ross J.W., Preston M., 2005; Maher C.M. et al., 2011; Sarlos D. et al., 2014). Несомненными

ограничениями в распространении данной методики являются и длительная кривая обучения (Manodoro S. et al., 2011). Для крестцово-остистой фиксации характерны такие осложнения, как рецидивирующее цистоцеле у 20-33% пациенток, а также диспареуния, частота которой может достигать 16% (Paraíso M.F.et al., 1996; Karram M.M. et al., 1999; Morgan D.M. et al., 2007).

Альтернативным направлением в лечении ПТО является протезирующая хирургия, основоположником которой является P. Petros, предложивший «замещать» дефектные крестцово-маточные связки синтетическим сетчатым эндопротезом-лентой (Petros P.P.E., 1997). С целью достижения единовременной коррекции I и II уровней поддержки при передне-апикальном пролапсе путем имплантации сетчатых эндопротезов были разработаны такие полноразмерные имплантаты, как Elevate® Anterior and Apical (AMS) и OPUR (ABISS), эффективно восстанавливающие ПТО в 90-97% случаев при сроках наблюдения до 3х лет (Su T.H. et al., 2014; Guymard A., Delorme E., 2016; Castellani D. et al.,2017). Среди отечественных полноразмерных эндопротезов необходимо отметить систему «Пелвикс Передний» (Линтекс, Санкт-Петербург), успевшую зарекомендовать себя для восстановления цистоцеле (Кубин Н.Д., Шкарупа Д.Д., 2014). Однако, осложнения, характерные для больших сеток (эрозии, нарушение мочеиспускания и т.д), остаются актуальными и для этих систем (Rapp D.E., с соавт., 2014; Su T.H., с соавт., 2014; Guyomard A., Delorme E., 2016).

Современной ступенью эволюции сетчатых эндопротезов для реконструкции тазового дна являются имплантаты с минимальными размерными характеристиками, направленные на восстановление апикального компартмента: UpHold (Boston Scientific), УроСлинг-1 (Линтекс, Санкт-Петербург) (Шкарупа Д.Д. с соавт., 2016; Jirschele K. et al.,2015). Необходимость сочетанного восстановления лобково-шеечной фасции при использовании подобных эндопротезов отразилась в дополнении сетчатой реконструкции пластикой собственными тканями и формулировании принципа «гибридной» хирургии тазового дна (Шкарупа Д.Д. с соавт., 2016; Кубин Н.Д. с соавт., 2017).

Таким образом, имеет место очевидная необходимость исследования эффективности и безопасности органосохраняющих хирургических методов, обеспечивающих единовременное восстановление апикального и переднего компартментов тазового дна, сочетающих в себе надежность синтетических имплантатов и безопасность нативной пластики, а также определения оптимального шовного материала для реконструкции эндопельвикальной фасции.

Цель исследования: Оптимизировать методику хирургического лечения передне-апикального пролапса тазовых органов влагалищным доступом.

Задачи

1. В эксперименте исследовать динамику механических свойств основных типов шовных материалов, применяемых для реконструкции фасциального аппарата тазового дна.

2. Изучить в эксперименте биомеханические свойства миофасциальных лоскутов, реконструированных с применением рассматриваемых типов хирургических нитей.

3. Оценить особенности реакции тканей животных на различные виды шовных материалов и сформировать на основе экспериментальных данных рекомендации по оптимальному выбору шовного материала для осуществления пластики фасциального аппарата тазового дна.

4. Изучить эффективность и безопасность хирургической коррекции передне-апикального пролапса с использованием полноразмерных сетчатых эндопротезов с одновременной троакарной трансобтураторной и крестцово-остистой фиксацией рукавов при двухлетнем наблюдении.

5. Изучить эффективность и безопасность хирургической коррекции передне-апикального пролапса с помощью гибридной методики реконструкции тазового дна при двухлетнем наблюдении.

6. Сравнить эффективность и безопасность применения полноразмерных сетчатых эндопротезов и гибридной методики реконструкции тазового дна при передне-апикальном пролапсе.

Научная новизна исследования

В эксперименте были изучены механические свойства шовных материалов in vitro и in vivo, оценена их динамика на трех сроках экспозиции, выявлены различия в указанных параметрах. Отличительной особенностью произведенного исследования хирургических нитей было изучение механических характеристик как в узле, так и без узла, в то время как производители шовного материала выполняют оценку прочностных характеристик только в узле.

В настоящей работе были оценены биомеханические параметры и гистологические характеристики миофасциальных лоскутов, целостность которых восстанавливалась с помощью основных видов шовных материалов, применяющихся для реконструктивных операций на тазовом дне.

Оценена эффективность и безопасность троакарной методики коррекции передне-апикального пролапса с использованием полноразмерного сетчатого имплантата «Пелвикс Передний». В отличии от ранее выполняемых реконструкций с помощью данного эндопротеза в настоящей работе осуществлялось восстановление не только II, но и I уровня поддержки (по DeLancey) за счет проведения задних рукавов эндопротеза через крестцово-остистые связки.

В рамках настоящей работы была оценена эффективность разработанной ранее с участием автора методики хирургической коррекции передне-апикального пролапса тазовых органов влагалищным доступом с использованием сетчатого эндопротеза и пластики фасциального аппарата тазового дна (патент РФ 2661042). Реконструкция фасциальных структур осуществлялась шовным материалом, выбранным на основании полученных экспериментальных данных.

Впервые была произведена сравнительная оценка эффективности и безопасности протезирующей вагинальной хирургии при передне-апикальном

пролапсе с применением полноразмерного сетчатого имплантата и гибридной методики, подразумевающей использование эндопротеза-ленты минимальных размерных характеристик.

Практическая значимость исследования

На основании результатов экспериментальной части диссертационного исследования были сформулированы рекомендации по выбору шовного материала для осуществления пластики фасциального аппарата тазового дна.

Исследование, проведенное на значительном клиническом материале, при двухлетнем наблюдении показало высокую эффективность органосохраняющей протезирующей реконструкции тазового дна вагинальным доступом при передне-апикальном пролапсе.

Сравнение двух использованных в настоящей работе хирургических техник выявило меньшее число «имплантат-ассоциированных» осложнений и побочных эффектов при выполнении методики гибридной реконструкции тазового дна при отсутствии значимых различий в объективной и субъективной эффективности. Использование в исследованной методике синтетического сетчатого имплантата российского производства («Линтекс», Санкт-Петербург) делает ее широкодоступной с точки зрения финансовой целесообразности для различных стационаров РФ в сравнении с импортными эндопротезами.

Основные положения, выносимые на защиту

1. Минимальные сроки формирования послеоперационного рубца, устойчивого к механическим нагрузкам, установленные в эксперименте, составляют не менее 14 дней. При использовании полиглекапроновых нитей, устойчивость послеоперационного рубца к механическим нагрузкам не превышает 48% на данном сроке, а нити теряют до 90% прочностных характеристик, что указывает на непригодность данного шовного материала для реконструкции фасциального аппарата тазового дна.

2. Оптимальные результаты реконструкции фасциального аппарата тазового дна могут быть достигнуты при использовании рассасывающихся нитей со средним или длительным сроком резорбции, применение нерассасывающегося шовного материала преимуществ не имеет. При субфасциальной кольпоррафии методика непрерывного шва позволяет сохранить большую прочность нити в сравнении с узловыми швами.

3. Протезирующие методики реконструкции тазового дна, осуществляемые вагинальным доступом, обладают высокой объективной и субъективной эффективностью при передне-апикальном пролапсе. Они обеспечивают нормализацию функционирования мочевого пузыря и улучшают качество жизни пациенток. При этом гибридная методика реконструкции тазового дна является альтернативой полноразмерному сетчатому эндопротезу, характеризуясь меньшим числом имплантат-ассоциированных интра- и послеоперационных осложнений.

Апробация и внедрение результатов в практику

Материалы диссертации представлены на 8-ом международном научном конгрессе «Оперативная гинекология - новые технологии» (Санкт-Петербург, 2016 год); научно-образовательном семинаре «Реконструкция тазового дна вагинальным доступом: от унификации к персонализации» (Санкт-Петербург, 2017 год); 3 Научно-практической конференции урологов Северо-западного федерального округа РФ (Санкт-Петербург, 2017 год); XVIII Всероссийском научно-образовательном форуме "Мать и Дитя - 2017" (Геленджик, 2017 год); 47 ежегодной конференции международного общества по удержанию - ICS (Флоренция, 2017 год); ежегодном конгрессе американской ассоциации урологов -AUA (Бостон, 2017 год); 32-ом ежегодном конгрессе европейского общества урологов - EAU (Лондон, 2017 год); IV Невском урологическом форуме (Санкт-Петербург, 2018 год); XXXI Международном конгрессе с курсом эндоскопии «Новые технологии в диагностике и лечении гинекологических заболеваний» (Москва, 2018 год); 44-ом ежегодном конгрессе международной

урогинекологической ассоциации - ШОА (Вена, 2018 год); 29-ом Всемирном конгрессе по видеоурологии и достижениям в клинической урологии (Москва, 2018 год).

Результаты работы внедрены в практику урологического и гинекологического отделений, отделения восстановления репродуктивного здоровья Клиники высоких медицинских технологий им. Н.И. Пирогова Санкт-Петербургского государственного университета.

Публикации

По теме диссертации опубликованы 8 статей в изданиях из перечня, рекомендуемого ВАК. Получено 2 патента на изобретение.

Личный вклад автора

Автором лично проведены экспериментальные исследования на 39 лабораторных животных (кролики), работы по изучению характеристик шовного материала условиях научно-производственной лаборатории предприятия-производителя, сформирована база данных и выполнена статистическая обработка полученных материалов.

Структура и объем диссертации

Диссертация состоит из введения, обзора литературы, описания материалов и методов исследования, двух глав исследований, заключения, выводов, практических рекомендаций, списка литературы. Диссертация изложена на 152 страницах машинописного текста, иллюстрирована 38 таблицами и 32 рисунками.

Библиографический указатель включает 205 работ, из них 28 отечественных и 177 зарубежные публикации.

Глава 1. ПРОЛАПС ОРГАНОВ МАЛОГО ТАЗА - СОВРЕМЕННОЕ

СОСТОЯНИЕ ПРОБЛЕМЫ (обзор литературы)

1.1 Эпидемиология и социально-экономическое значение пролапса тазовых

органов

Пролапс тазовых органов (ПТО) - это состояние, при котором вследствие нарушения анатомической целостности связочно-фасциальных структур малого таза происходит опущение стенок влагалища и органов малого таза (матка, мочевой пузырь, кишечник). Вопрос эпидемиологии генитального пролапса является неоднозначным: распространенность заболевания, по данных исследований, разнится в широких пределах от 2,9% до 75% в зависимости от выбранных критериев оценки (Swift S.E. et al., 2003; Nygaard I. et al., 2008; Wilkins M.F., Wu J.M., 2016; Li Z. et al., 2018). Так, согласно ряду отечественных источников, ПТО наблюдается у 15-30% женщин, достигая 40% в возрастной группе старше 50 лет (Краснопольский В.И. с соавт., 2010; Коршунов М.Ю., 2017). Призывая к стандартизации оценки генитального пролапса, международные урогинекологические ассоциации предлагают использовать систему POP-Q (Pelvic Organ Prolapse Quantification System) (Bump R.C., 1996). В мультицентровом обсервационном исследовании, включавшем 1004 женщины в возрасте от 18 до 83 лет, проходивших рутинное гинекологическое обследование наблюдалось следующее распределение по стадиям пролапса согласно классификации POP-Q: 0 стадия определялась у 24% женщин, I - у 38%, II - у 35% и III - у 2% (Swift S., 2005). Согласно данным исследования «Инициативы во имя здоровья женщины» (Women's Health Initiative), среди женской популяции в возрастной группе 50-79 лет какая-либо степень пролапса определялась с частотой 41%. При этом преобладающей формой пролапса тазовых органов являлось опущение передней влагалищной стенки, или цистоцеле, наблюдавшееся у каждой третьей женщины (Hedrix S.L. et al., 2002). Однако необходимо отметить, что основной недостаток систем анатомической оценки пролапса связан

с отсутствием учета симптоматики. Как известно, асимптомное опущение органов малого таза не является показанием для каких-либо хирургических вмешательств. В связи с этим целесообразно учитывать не только сам факт опущения, но и обеспокоенность пациенток этим состоянием. По данным исследования, проведенного в Великобритании, среди 1832 женщин из общебольничной сети 8,4% сообщали о наличии ощущения инородного тела в области промежности (Cooper J. et al., 2015). При этом опубликованы данные, свидетельствующие о том, что только 10-20% пациенток, имевших симптомы опущения, обращались по этому поводу за медицинской помощью (Doaee M. et al., 2014; Cooper J. et al., 2015). Эти цифры указывают на другую проблему в эпидемиологии ПТО -низкую обращаемость за медицинской помощью. Женщины длительное время живут с данной проблемой в связи с наличием психологического барьера (они стыдятся своего состояния), а также в виду предубеждений о том, что генитальный пролапс - это состояние, ассоциированное со старением. Таким образом, можно полагать, что истинные цифры распространенности ПТО, требующего лечения, превышают публикуемые.

Несмотря на то, что пик заболеваемости ПТО приходится на возраст 60-69 лет, значимая доля пациенток с пролапсом - это женщины трудоспособного возраста (Кулаков В.И., 2004). Генитальный пролапс, особенно в выраженных стадиях, ассоциирован с различными видами функциональных нарушений таких как недержание мочи, неполное опорожнение мочевого пузыря, обструктивная дефекация и сексуальные нарушения (Радзинский B.E. с соавт., 2008; Русина Е.И., 2018; Fritel X. et al., 2009; Espuna-Pons M. et al., 2014). Согласно имеющимся публикациям, более 50% женщин с симптомами ПТО имеют одно из следующих расстройств: стрессовое недержание мочи, недержание кала и/или гиперактивный мочевой пузырь (Lawrence J.M. et al., 2008). Женщины с пролапсом могут иметь широкий спектр симптомов расстройств нижних мочевых путей: стрессовое недержание мочи в 40% случаев, ургентность - в 34%, учащенное мочеиспускание - в 29%, ургентное недержание мочи - в 30% (De Boer T.A. et al., 2011; Cetinkaya S.E. et al., 2013). При этом усугубление симптоматики часто

связано с прогрессированием пролапса. Как правило, наиболее явная корреляция между субъективными жалобами и объективным статусом прослеживается при цистоцеле (Cetinkaya S.E. et al., 2013). Несмотря на то, что генитальный пролапс не является жизнеугрожающим заболеванием, он значимо снижает качество жизни пациенток, ограничивая круг повседневных занятий и способствуя их социальной дезадаптации, а при запущенных стадиях может приводить к хронической задержке мочи, уретерогидронефрозу и рецидивирующим инфекциям мочевыводящих путей (Jelovsek J.E. et al.,2007; Costantini E. et al., 2009; Machida S. et al., 2017; Mao M. et al., 2018).

Неуклонный рост заболеваемости ПТО происходит как за счет повышающегося числа молодых женщин, страдающих данным заболеванием, так и за счет увеличения продолжительности жизни (Радзинский B.E. с соавт., 2008; Chow D., Rodríguez, L. V., 2013). По данным американских коллег, в связи с прогнозируемым увеличением числа лиц пожилого возраста в США, к 2050 году ожидается возрастание распространенности ПТО в популяции на 46% по сравнению с данным за 2010 год (с 3,3 миллионов до 4,9), а число оперативных вмешательств по поводу пролапса увеличится с 166 000 в год до 245 970 (Wu J.M., 2009). Такое увеличение заболеваемости неминуемо приведет к необходимости дополнительного финансирования медицинской помощи по данной нозологии, а также подготовки медицинских кадров, способных адекватно и в полном объеме ее оказать. Ежегодные расходы в США на амбулаторную помощь пациенткам с расстройствами тазового дна с 2005 по 2006 год составили почти 300 млн долларов (Sung V.W., 2010). В то же время хирургическое лечение пролапса было наиболее распространенной процедурой, выполняемой в стационаре женщинам в возрасте старше 70 лет с 1979 по 2006 год (Oliphant S.S., 2010). Очевидно, что эта закономерность будет сохраняться. В нашей стране ежегодно производится более 50 000 операций по поводу ПТО, из которых не менее трети связаны с рецидивом заболевания (Буянова С.Н. с соавт., 2017). Несмотря на то, что хирургическое лечение во всем мире признано единственным методом, обеспечивающим высокую и долгосрочную эффективность коррекции выраженных форм опущения

стенок влагалища и матки, вопрос экономической составляющей этого лечения недостаточно освещен. Авторы одного из таких исследований отметили, что в 2005 году в Германии, Франции и Великобритании выполнялась 1 операция, направленная на устранение ПТО, на 1000 женщин, при этом годовые расходы на обеспечение данного лечения в этих странах составили 144, 83 и 81 млн евро, соответственно (Subramanian D. et al., 2009). Столь существенные финансовые затраты привели к необходимости оценки хирургических методик реконструкции тазового дна не только с позиций эффективности и безопасности, но и экономической целесообразности.

Другой немаловажной проблемой является создание стандартизованных оперативных вмешательств, которые могли бы быть освоены молодыми специалистами в относительно короткие сроки. Так, опрос выпускников университета Техасского Юго-Западного Медицинского центра (Даллас, Техас), прошедших резидентуру по акушерству и гинекологии в период с 1997 по 2006 годы, выявил наличие необходимых знаний в диагностике ПТО и недержания мочи при недостаточных практических навыках в лечении данных заболеваний. Наиболее часто выполняемым вмешательством при генитальном пролапсе как во время резидентуры, так и самостоятельной практики была названа передняя/задняя кольпоррафия (Casiano E.R., 2012).

1.2 Современное представление о патогенезе передне-апикального

пролапса гениталий

Генитальный пролапс - заболевание, которое было известно уже за 1,5 тысячи лет до нашей эры (Shah S.S. et al., 2006). На тот момент матка воспринималась как самостоятельное животное, способное перемещаться внутри организма и выходить наружу, становясь диким без мужского семени (Barbalat Y., Tunuguntla H. S. G. R., 2012). Спустя три тысячелетия были изучены анатомия и физиология органов малого таза, определено гистологическое строение и значение фасциальных структур, проведено множество исследований,

открывших, в том числе, особенности генов и матриксных металлопротеиназ у женщин с ПТО (Сухих Г.Т. с соавт., 2012; Радзинский В.Е. с соавт., 2014; Moalli P.A. et al., 2005; Phillips C.H. et al., 2006; Brizzolara S.S. et al., 2009). Исследователями были предложены несколько весьма логичных моделей формирования генитального пролапса (Bump R.C., Norton P., 1998; DeLancey J.O.L. et al., 2008). Глобально патогенез ПТО можно описать следующим образом: под действием провоцирующих факторов возникают повреждения связочно-фасциальных и мышечных структур тазового дна, что в сочетании с имеющейся предрасположенностью и воздействием способствующих механизмов приводит к развитию ПТО. Ведущим провоцирующим моментом являются осложнения родов, проводимых через естественные родовые пути (Levin P.J. et al., 2012; Gyhagen M. et al., 2012; Memon H, Handa VL., 2012; Blomquist J. L. et al., 2018). Риск пролапса повышается после родов крупным плодом (Nygaard I. et al., 2004, Gyhagen M. et al., 2012), оперативном родоразрешении с использованием щипцов (Chan S.S. et al., 2011; Handa V.L. et al., 2012; Blomquist J. L. et al., 2018), перенесенных в родах разрывах промежности (Bertozzi S., et al., 2011; Memon H, Handa VL., 2012). На развитие ПТО также влияет и возраст матери на момент первых родов. Так, Leijonhufvud А. с соавторами выявили необходимость в хирургическом лечении ПТО у 14% женщин с первым родами в возрасте старше 30 лет, против 6% в группе первородящих моложе этого возраста. К предрасполагающим факторам развития генитального пролапса относятся, так называемые, немодифицируемые факторы: возраст, раса, анатомические особенности, менопаузальный статус, генетическая предрасположенность, хронические обструктивные заболевания легких, дисплазия соединительной ткани, нейропатии (Bump R.C., Norton P., 1998; DeLancey J.O.L. et al., 2008; Chow, D., Rodriguez, L. V., 2013). Так, в исследовании, проведенном Alcalay M. с соавторами, семейный анамнез опущения органов малого таза у пациенток, оперированных по поводу ПТО в возрасте моложе 45 лет, встречался в 5 раз чаще, чем у пациенток старшей возрастной группы (>55 лет), перенесших аналогичное лечение (Alcalay M. et al., 2015). Ранее было выявлено, что 30% пациенток той же

возрастной группы (моложе 45 лет), обращавшихся за оперативным лечением генитального пролапса, имели родственниц первой степени родства, страдавших ПТО (Rinne K. M., Kirkinen P. P., 1999). Возраст признан неотъемлемым фактором развития дисфункции тазового дна и ПТО. В поперечном исследовании, проведенном в группе женщин в возрасте от 18 до 83 лет было определено, что распространенность пролапса увеличивалась примерно на 40% с каждым десятилетием жизни (Swift S. et al., 2005). Генетические факторы, возрастные изменения и, прежде всего, гипоэстогенемия приводят к патологическому состоянию тканей на уровне соотношений эластина и коллагена, к повышенной активности протеаз, приводящих к деградации межклеточного матрикса (Радзинский В.Е. с соавт., 2014; Imokawa G. et al., 1995; Phillips C.H. et al., 2006; Kerkhof M.H. et al., 2009). Немаловажную роль имеет генетически детерминированная системная дисплазия соединительной ткани (Miedel A. et al., 2009). Так, мутации в гене фибриллина-1 вызывают синдром Марфана, в симптомокомплекс которого входит пролапс органов малого таза (Carley M.E., Schaffer J., 2000).

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FSBRI REASERCH INSTITUTE OF OBSTETRICS, GYNECOLOGY AND REPRODUCTOLOGY N.A.OTT

Manuscript copyright

Shapovalova Ekaterina Andreevna

UTERUS-SPARING VAGINAL MESH-BASED RECONSTRUCTION OF THE PELVIC FLOR FOR THE ANTERIOR-APICAL PROLAPSE

(clinically-experimental research)

14.01.01 - Obstetrics and Gynecology

Dissertation is submitted for the degree of candidate of medical sciences

Scientific director Doctor of medical sciences E.N. Popov

Saint-Petersburg 2019

CONTENTS

INTRODUCTION..................................................................................156

Chapter 1. PELVIC ORGAN PROLAPSE - CURRENT STATUS OF THE PROBLEM (literature review)

1.1. Epidemiology and socio-economic value of the pelvic organ prolapse.............163

1.2. The modern understanding of pathogenesis of the anterior-apical prolapse.....166

1.3. The evolution of the surgical techniques for the treatment of the anterior-apical prolapse................................................................................................169

1.4. Suture materials for the approximation of endopelvic fascia structures.........182

1.5. Efficacy and safety of hysterectomy for the treatment of anterior-apical prolapse.........................................................................................185

Chapter 2. MATERIALS AND METHODS OF THE STUDY

2.1. Materials and methods of the experimental research..............................190

2.1.1. In vitro study of the mechanical properties of the suture materials.....190

2.1.2. In vivo study...................................................................191

2.1.2.1. Mechanical properties of suture materials.......................195

2.1.2.2. Biomechanical properties of myofascial flaps created with the use of studied suture materials.............................................195

2.1.2.3. Histological characteristics of the scar tissue.....................196

2.2. Materials and methods of clinical research...........................................198

2.2.1. General characteristics of patients...........................................198

2.2.2. Preoperative examination of patients........................................199

2.2.3. Postoperative management of patients.......................................200

2.3. Methods of statistical data analysis...................................................201

Chapter 3. RESULTS OF THE EXPERIMENTAL RESEARCH

3.1. Mechanical properties of the studied suture materials in vitro.......................202

3.2. Results of the in vivo study...............................................................205

3.2.1. Macroscopic evaluation of suture samples and postoperative scars.....205

3.2.2. Mechanical properties of the studied suture materials in vivo..............209

3.2.3. Biomechanical properties of the myofascial flaps created with the use of studied suture materials...................................................................................212

3.2.4. Features of the tissue reaction in animal model to various types of suture material............................................................................................................216

Chapter 4. RESULTS OF THE SURGICAL TREATMENT OF THE ANTERIOR-APICAL PROLAPSE THROGH THE VAGINAL ACCESS WITH THE USE OF SYNTHETIC MESH IMPLANTS

4.1. Results of the treatment of patients with the anterior-apical prolapse using a full-size implant "Pelvix Anterior"...................................................................................226

4.1.1. Surgical technique.................................................................................226

4.1.2. Results of the treatment of patients with the use of the implant "Pelvix Anterior"..........................................................................................................228

4.2. Results of the hybrid surgical reconstruction of the pelvic floor for the treatment of patients with anterior-apical prolapse

4.2.1. Surgical technique.................................................................................234

4.2.2. Results of the treatment of patients using the hybrid technique of pelvic floor reconstruction.........................................................................................236

4.3. Comparison of the effectiveness of the treatment of patients with anterior-apical prolapse between the two groups..............................................................................242

CONCLUSION.............................................................................................................252

SUMMARY..................................................................................................................262

PRACTICAL RECOMMENDATIONS.......................................................................264

LIST OF THE ABBREVIATIONS..............................................................................265

REFFERENCES

266

INTRODUCTION

Actuality of the study

Pelvic organ prolapse (POP) is one of the most common gynecological pathologies in middle-aged and older women. POP is detected in 15-30% of women, reaching 40% in the age group over 50 years (Krasnopol'sky V.I., et al., 2010; Korshunov M.Yu.,

2017). Genital prolapse is extremely rarely the cause of conditions which present direct threat to the life, but it leads to functional disorders of the bladder and rectum, reduces the patients' quality of life and limiting the range of daily activities and contributing to their social disadaptation (Radzinsky V.E. et al., 2008; Rusina E. I., 2018; Jelovsek J.E. et al., 2007; Fritel X. et al., 2009; Mao M. et al., 2018).

Among the various forms of POP, prolapse of the anterior vaginal wall, cystocele, is observed in every third woman, takes the leading position (Hendrix S.L. et al., 2002). At the end of the 19th century the first attempts of its surgical correction were already made which consisted in the excision of excess volume of mucosal tissues and their subsequent plication (Sims J.M., 1866). The described technique had many variants of performance, and was given the name "colporrhaphy", however the problem of the absence of the standardization of this technique, noted in the 90s of the 20th century, remains up to the present day (Weber A., Walters M., 1997; Harpen-Elenskaia K. et al.,

2018). The suture material plays an important role in this type of the surgery as it resists the load of intra-abdominal pressure until a firm scar is formed (Petros P.E.P., 1998). However, at present, the choice of suture material continues to be based only on the individual preferences of the surgeon (Bergman I. et al., 2016; Harpen-Elenskaia K. et al., 2018).

The efficiency of anterior colporrhaphy according to the researches is within wide limits: from 70.0% to 97.3% (Porges R.F., Smilen S.W., 1994; Weber A.M. et al., 2001). The reason of low efficiency of this intervention may be the absence of simultaneous correction of the apical support, which leads to recurrence in 58% of patients in a year after the surgery (Kenton K. et al., 1999). The close connection between I and II levels of support (according to DeLancey) indicates the rationality of

isolating the anterior-apical form of the prolapse that requires an appropriate simultaneous "two-level" reconstruction (Summer A. et al., 2006; Lowder J.L. et al., 2008; Elliot C.S. et al., 2013).

The connection between cystocele and uterocele reflected in the historically formed idea concerning the necessity of removal of the uterus, performing hysterectomy, to eliminate POP (Baerj L. et al., 1937; Arthure H. G. E., Savage D., 1957). Despite the fact that this volume of surgery is not justified considering the pathogenesis, up to the present day, hysterectomy remains one of the most popular surgery for pelvic organ prolapse (Whiteman M. K. et al., 2008). At the same time, hysterectomy performed in case of POP leads to the development of posthysterectomy prolapse in 0.2-45.0% of cases (Flynn B.J., Webster G.D., 2002; Dällenbach P. et al., 2008; Nyyssönen V. et al., 2013). It is necessary to notice that women themselves are often not ready to be deprived of the uterus in the absence of vital indications for this intervention (Neuman M., Lavy Y., 2007; Korbly N. B. et al., 2013; Meriwether K. V. et al., 2018).

Talking about the repair of the apical support (level I, according to DeLancey), among the most common techniques are abdominal sacrocolpopexy and vaginal sacrospinous ligament fixation. The efficiency of both techniques, according to a number of studies, reaches 90-96%, however, these interventions have a number of specific complications (Hefni M.A., El-Toukhy T.A., 2006; Sarlos D. et al., 2008; Ganatra A.M. et al., 2009; Meuman N. et al., 2014). Thus, the performance of sacrocolpopexy can be complicated by severe blood loss in 4.4% of cases and the obstructive defecation developed in 4.7-50.0% of patients in the postoperative period (Nygaard I.E. et al.,2004; Ross J.W., Preston M., 2005; Maher C.M. et al., 2011; Sarlos D. et al., 2014). A doubtless limitation in the spreading of this technique is a long-time learning curve (Manodoro S. et al., 2011). The recurrent cystocele in 20-33% of patients as well as dyspareunia, the occurrence rate of which can reach 16%, are specific complications of sacrospinous fixation (Paraiso M.F. et al., 1996; Karram M.M. et al., 1999; Morgan D.M. et al., 2007).

An alternative direction in the treatment of POP is mesh-based surgery, the founder of which is P. Petros, who proposed to "replace" weak uterosacral ligaments with a synthetic tape (Petros P.P.E., 1997). The full-size implants such as Elevate Anterior and Apical (AMS) and OPUR (ABISS) were developed in order to achieve the simultaneous correction of I and II levels of support for anterior-apical prolapse by the way of installation of mesh implant which repaired POP efficiently in 90-97% of cases for the follow-up period up to 3 years (Su T.H. et al., 2014; Guymard A., Delorme E., 2016; Castellani D. et al., 2017). Among the Russian full-size implants, it is necessary to note the system "Pelvix Anterior" (Lintex, Saint-Petersburg) that was in time to prove itself to be good for the cystocele repair (Kubin N.D., Shkarupa D.D., 2014). However, the complications specific for full-size meshes (erosion, micturition disorder, etc.) remain relevant for these systems (Rapp D.E., et al., 2014; Su T.H., et al., 2014; Guyomard A., Delorme E., 2016).

The modern stage of the evolution of the mesh implants for the pelvic floor reconstruction are the implants with minimal dimensional characteristics aimed at the repair the apical compartment: UpHold (Boston Scientific), UroSling-1 (Lintex, Saint-Petersburg) (Shkarupa D. et al., 2016; Jirschele K. et al., 2015). The necessity of combined restoration of the pubocervical fascia with the use of such implants was reflected in the combination of mesh reconstruction with native tissue repair and the formulation of the principle of "hybrid" repair of pelvic floor (Shkarupa D.D. et al., 2016; Kubin N.D. et al., 2017).

Thus, the evident necessity of the research of the efficiency and safety of uterine-sparing surgical techniques that provide a simultaneous restoration of the apical and anterior pelvic compartments which combine the reliability of synthetic implants and the safety of native tissue repair as well as to determine the optimal suture material for endopelvic fascia reconstruction takes place.

Purpose of the study: to optimize the method of the surgical treatment of anterior-apical prolapse via vaginal access.

Objectives of the study:

1. To evaluate in the experiment, the dynamics of mechanical features of the main types of suture materials, that are used for the reconstruction of the fascial structures of pelvic floor.

2. To study experimentally the biomechanical properties of myofascial flaps reconstructed with the use of considered types of surgical sutures.

3. To assess the characteristics of the response of animal tissues to various types of suture materials and, based in the experimental data, form recommendations on the optimal choice of suture material for reconstruction of endopelvic fascia.

4. To study the efficacy and safety of surgical correction of anterior-apical prolapse with the use of full-size mesh with simultaneous trocar transobturator and sacrospinous ligament fixation of the arms during two years of follow-up.

5. To study the efficacy and safety of surgical correction of anterior-apical prolapse with the use of the hybrid technique of pelvic floor reconstruction for two years of follow-up.

6. To compare the efficacy and safety of the use of the full-size mesh and the hybrid the hybrid technique of pelvic floor reconstruction for the treatment of anterior-apical prolapse.

Scientific novelty of the study

The mechanical properties of suture materials in vitro and in vivo were studied in the experiment. Their dynamics at three periods of exposure was evaluated, the differences in the indicated parameters were revealed. A distinctive feature of the performed research of surgical sutures was the study of mechanical characteristics both in a simple knot and without a knot. While the manufacturers of suture materials perform an assessment of the strength characteristics only in the knot.

In the present work the biomechanical parameters and histological characteristics of myofascial flaps, reconstructed with the use of the main types of suture materials used for the reconstructive surgery of the pelvic floor, were evaluated.

The efficacy and safety of the anterior-apical prolapse trocar correction using full-size mesh implant "Pelvix Anterior" was evaluated. In contrast to the previously performed reconstructions using this implant in the present work, not only II, but also I level of support was restored by the carrying out the posterior arms of the implant through the sacrospinous ligaments.

Within the limits of the present work the efficiency of the earlier developed with the author participation technique for surgical correction of anterior-apical prolapse through a vaginal access with the use of the synthetic tape and native tissue repair (Patent RU2661042) was valued. The reconstruction of fascial structures was performed with the use of suture material chosen on the basis of the obtained experimental data.

The comparative assessment of the efficacy and safety of mesh-based vaginal surgery for anterior-apical prolapse with the use of a full-size mesh implant and a hybrid technique involving the use of a synthetic tape with minimal dimensional characteristics was performed for the first time.

The practical relevance of the study

The recommendations on the choice of suture material for the reconstruction of the pelvic floor fascial structures were formulated based on the results of the experimental part of the dissertation research. The study conducted on significant clinical material during two-year follow-up showed high efficacy of uterine-sparing mesh-based reconstruction of the pelvic floor through vaginal access for anterior-apical prolapse.

The comparison of two surgical techniques in the present research revealed a smaller number of "implant-associated" complications and side effects when performing the technique of hybrid pelvic floor reconstruction in the absence of significant differences in objective and subjective efficiency. The use of the synthetic mesh implant made in Russia (Lintex, Saint-Petersburg) in the studied technique makes it widely available from the point of view of financial feasibility for various hospitals of the Russian Federation in comparison with foreign implants.

The main provisions for the thesis defense

1. The minimum time for the formation of a postoperative scar resistant to mechanical loads, established in the experiment, is at list 14 days. When polyglecaprone threads are used, the resistance of the postoperative scar to mechanical loads does not exceed 48% at this time, and the threads lose up to 90% of the strength characteristics, which indicates the unsuitability of this suture material for the reconstruction of the fascial structures of pelvic floor.

2. Optimal results of the reconstruction fascial structures of pelvic floor can be achieved with the use of absorbable sutures with an average or long term of resorption, the use of nonabsorbable suture material has no advantages. With subfascial colporrhaphy, the continuous suture allows to maintain greater strength of the thread in comparison with interrupted sutures.

3. Mesh-based vaginal techniques of pelvic floor reconstruction have high objective and subjective efficiency for the treatment of anterior-apical prolapse. They provide normal functioning of the bladder and improve patient's quality of life. At the same time, the hybrid technique of pelvic floor reconstruction is an alternative to a full-size mesh, characterized by a smaller number of implant-associated intra- and postoperative complications.

Evaluation and implantation of the work

The materials of the study were presented: at 8th International Scientific Congress "Surgical gynecology - New technologies" (Saint-Petersburg, 2016); the scientific and educational seminar "Vaginal reconstruction of the pelvic floor: from unification to personalization" (Saint-Petersburg, 2017); the 3 Scientific and practical Conference of urologists of the North-Western Federal District of the Russian Federation (Saint-Petersburg, 2017); the All-Russian scientific and educational Forum "Mother and Child - 2017" (Gelendzhik, 2017), 32 European Association of Urology (EAU) Congress (London, UK, 2017); American Urological Association's (AUA) Annual Meeting (Boston, USA, 2017; San-Francisco, USA, 2018); 47 Annual Meeting of the International Continence Society (ICS) (Florence, Italy, 2017); XXXI International Congress with a course of endoscopy "New technologies in the diagnosis and treatment

of gynecological disorders" (Moscow, 2018); IV Nevsky Urological Forum (Saint-Petersburg, 2018); 44 Annual Meeting of the International Urogynecological Association (IUGA) (Austria, Vienna, 2018); the 29 World Congress on Videourology and Acheivements in Clinical Urology (Moscow, 2018).

The results of the study were introduced into the practice of urology and gynecology departments, and the department of reproduction health restoration of the Saint-Petersburg State University Clinic of the Advanced medical technologies n.a. N.I. Pirogov.

Publications

8 articles on the subject of the thesis have been published in the editions indicated in the list recommended by the Higher Attestation Commission. 2 patents of the Russian Federation have been received.

The personal contribution of the author

The author personally conducted the following elements of the study: experimental studies on 39 laboratory animals (rabbits), work on studying the characteristics of suture material in the conditions of the research and production laboratory of the manufacturing enterprise, creating of the database and statistical analysis of obtained data.

The structure and the volume of the dissertation

The dissertation consists of introduction, literature review, description of material and study methods, two volumes of the study results, conclusion, summary, practical recommendations, list of references. The dissertation contains 136 pages of typewritten text, illustrated with 38 tables and 32 figures. The list of references consists of 205 works, including 28 Russian and 177 foreign publications.

Chapter 1. PELVIC ORGAN PROLAPSE - CURRENT STATUS OF THE PROBLEM

(literature review)

1.1. Epidemiology and socio-economic significance of pelvic organ prolapse

Pelvic organ prolapse (POP) is a condition in which vaginal walls and pelvic organs (uterus, bladder, intestines) descend below the hymen due to the injury of the anatomical integrity of ligaments and fascial structures of the pelvic floor. The epidemiological aspect of genital prolapse is ambiguous: the rate of this disease, according to the research data varies widely from 2.9% to 75% depending on the selected assessment criteria (Swift S.E. et al., 2003; Nygaard I. et al., 2008; Wilkins M.F., Wu J.M., 2016; Li Z. et al., 2018). Thus, according to a number of Russian studies, POP is observed in 15-30% of women, reaching 40% in the age group over 50 years (Krasnopol'sky V.I. et al., 2010; Korshunov M.Yu., 2017). The international urogynecological associations appeal to the standardized assessment of the genital prolapse, suggesting the use the POP-Q system (Pelvic Organ Prolapse Quantification System) (Bump R.C., 1996). In a multicenter observational study, which included 1004 women aged from 18 to 83 years who underwent a routine gynecological examination, the prolapse was categorized in the following stages according to the POP-Q assessment: 0 stage was determined in 24% of women, I - in 38%, II - in 35 % and III -in 2% (Swift S., 2005).

According to the research data of the Women's Health Initiative any stage of the prolapse is determined in 41% of the female population in the age group of 50-79 (Hedrix S.L., et al., 2002). With that the predominant type of pelvic organ prolapse is the prolapse of the anterior vaginal wall, or cystocele, which is observed in every third woman (Hedrix S.L., et al., 2002). However, it is necessary to emphasize the deficiency of systems for anatomical evaluation of the prolapse which is associated with the lack of symptoms consideration. It is known, asymptomatic pelvic organ prolapse doesn't require any surgical interventions. In this regard, it is rational to take into account not only the fact of the prolapse, but also how this condition affects the women. According

to the study conducted in the UK, among 1832 women from the general hospital network, 8.4% informed about the sense of the presence of foreign body below the hymen (Cooper J., et al., 2015). It is interesting, that only 10-20% of patients with symptoms of prolapse address for medical help on this issue (Doaee M., et al., 2014; Cooper J., et al., 2015). These figures point at another problem in the epidemiology of POP - rare appeal for medical care. Women live for a long time with this problem due to the presence of a psychological barrier (they are ashamed of their state), and also in view of the prejudice that genital prolapse is a condition associated with aging. Thus, it can be assumed that the true prevalence rate of POP exceeds the published one.

Despite the fact that the peak incidence appears in the age group of 60-69, a significant part of patients with prolapse are women of working age (Kulakov V.I., 2004). Genital prolapse, especially at advanced stages, is associated with various types of functional disorders such as urinary incontinence, incomplete bladder emptying, obstructive defecation and sexual disorders (Radzinsky B.E. et al., 2008; Rusina E.I. 2018; Fritel X. et al., 2009; Espuna-Pons M. et al., 2014). According to the present publications, more than 50% of women with symptoms of POP have one of the following disorders: stress urinary incontinence, fecal incontinence and / or overactive bladder (Lawrence J.M. et al., 2008). Women with genital prolapse may have a wide range of symptoms of lower urinary tract: stress urinary incontinence in 40% of cases, urgency - in 34%, frequent urination - in 29%, urgent urinary incontinence - in 30% (De Boer T.A. et al., 2011; Cetinkaya S.E. et al., 2013). At the same time, the prolapse progression is associated with the increase of the symptoms. The most obvious correlation between subjective complaints and objective status can be observed in women with cystocele (Cetinkaya S.E. et al., 2013). POP significantly reduces the patients' quality of life, limiting the range of daily activities and contributing to their social disadaptation (Jelovsek J.E. et al., 2007; Mao M. et al., 2018). Despite the fact that genital prolapse doesn't present direct threat to the life, at extensive stages it can lead to chronic urinary retention, ureterohydronephrosis and recurrent urinary tract infections (Costantini E. et al., 2009; Machida S. et al., 2017).

Besides, the widespread prevalence of POP, the steady growth of the incidence of the disease is marked both due to the increase of life expectancy and the rise of the number of young women suffering from this disease (Radzinsky V.E., et al., 2008; Chow D., Rodriguez, L.V., 2013). According to the data of an American colleagues, due to the predicted increase of the number of aged people in the United States by 2050, the rate of POP is expected to increase 46% in comparison with 2010, from 3.3 million to 4.9. And the number of interventions for prolapse will increase from 166,000 per year to 245,970 (Wu J.M., 2009). Such an increase of the incidence of the disease will lead to the necessity of additional funds for medical care in this pathology, and also to the training of medical specialists able to provide this care adequately and fully. Almost $ 300 million were spent in US on the outpatient care for patients with pelvic organ prolapse from 2005 to 2006 (Sung V.W., 2010). At the same time, from 1979 to 2006 surgical treatment of genital prolapse was the most common procedure performed in a hospital for women over 70 (Oliphant S.S., 2010). Obviously, this pattern will be maintained. In our country, more than 50,000 operations for POP are performed annually, 30% of which are associated with the disease recurrence (Buyanova S.N. et al., 2017).

Despite the fact that surgical treatment is recognized worldwide as the only method with its high and long-term effectiveness for the correction of advanced stages of prolapse, also few studies evaluating the economic aspect of this treatment were published. The authors of one of these studies noted that in Germany, France and the UK, 1 operation for POP per 1,000 women was performed in 2005 (Subramanian D., et al., 2009). The annual costs for the treatment in these countries amounted to 144, 83 and 81 million euro, respectively. Such essential financial injections led to the necessity to revise the position of the surgery for genital prolapse, and today the clinicians face the task to evaluate not only the efficiency and safety of the surgical technique, but economic feasibility as well.

An important problem is the creation of standardized surgical technique that could be learn by young specialists in a relatively short time. So, a survey of graduates of the University of Texas Southwestern Medical Center (Dallas, Texas) who completed

residency in Obstetrics and Gynecology from 1997 to 2006, confirmed the presence of necessary knowledge for the diagnosis of POP and urinary incontinence whereas in contrast the level of practical skills for the treatment of these diseases was insufficient. Anterior / posterior colporrhaphy was the most commonly performed intervention for genital prolapse both during residency and in private practice (Casiano E.R., 2012).

1.2. The modern understanding of pathogenesis of the anterior-apical prolapse

Genital prolapse is a disease that was already known 1,5 thousand years B.C. (Shah S.S. et al., 2006). At that moment, the uterus was considered as an independent animal able to move inside the body and go out becoming wild without a male seed (Barbalat Y., Tunuguntla H. S. G. R., 2012). Three thousand years later, the anatomy and physiology of the pelvic organs were studied, the histological structure of fascial structures was determined, and many studies which among other things revealed the features of genes and matrix metalloproteinases in women with POP were carried out (Sukhikh G.T. et al. 2012; Radzinsky V.E. et al., 2014; Moalli P.A. et al., 2005; Phillips C.H. et al., 2006; Brizzolara S.S. et al., 2009). Researchers proposed several quite logic models of the development of genital prolapse (Bump R.C., Norton P., 1998; DeLancey J.O.L. et al., 2008). Globally, the pathogenesis can be described as follows: under the influence of inciting factors, the damage to the ligamentous and fascial system and muscular structures of the pelvic floor occurs, which, in combination with the existing predisposition and exposure to the promoting mechanisms, leads to the development of POP. Vaginal delivery is a leading factor among other inciting (Levin P.J. et al., 2012; Gyhagen M. et al., 2012; Memon H., Handa V.L., 2012; Blomquist J.L. et al., 2018). The risk of the prolapse increases after delivery complicated by a large fetus (Nygaard I. et al., 2004, Gyhagen M. et al., 2012), operative delivery using forceps (Chan S.S. et al., 2011; Handa V.L. et al., 2012; Blomquist J.L. et al., 2018), perineal tears (Memon H., Handa V.L., 2012; Bertozzi S. et al., 2011). The age of the mother at the time of the first delivery also influences on the prolapse development. Thus, Leijonhufvud A. and colleagues revealed the necessity for surgical treatment of POP in 14% of women who

gave first birth over the age of 30, versus 6% in the group of primiparas younger this age. The predisposing factors for the development of genital prolapse include the so-called non-modifiable factors: age, race, anatomical features, menopausal status, genetics, chronic obstructive lung diseases, connective tissue dysplasia, neuropathy (Bump R.C., Norton P., 1998; DeLancey J.O.L. et al., 2008; Chow D., Rodriguez, L.V., 2013). Thus, in a study conducted by Alcalay M. and colleagues, a family history of pelvic organ prolapse in the study group was 5 times more frequent than in the control group (Alcalay M. et al., 2015). Among women younger 45 years who applied for surgical treatment of genital prolapse, 30% of women had first-degree relatives with the prolapse (Rinne K.M., Kirkinen P.P., 1999). The age is recognized as an integral factor in the development of pelvic floor dysfunction and POP. In a cross-sectional study conducted in a group of women aged 18 to 83 years, it was determined that the prevalence of prolapse increased by 40% with each decade of life (Swift S., et al., 2005). Genetic factors, age-related changes and, above all, hypoestrogenemia lead to the pathology of tissues: in elastin and collagen proportion and increased activity of proteases leading to the degradation of intercellular matrix (Radzinsky V.E. et al., 2014; Imokawa G. et al., 1995; Phillips C.H. et al., 2006; Kerkhof M.H. et al., 2009). Genetically determined systemic connective tissue dysplasia plays an important role in the development of POP (Miedel A. et al., 2009). Thus, mutations in the fibrillin-1 gene cause Marfan syndrome, the symptom group of which includes pelvic organ prolapse (Carley M.E., Schaffer J., 2000).

The promoting factors of the development of POP are modifiable, they include: obesity, smoking, chronic constipation, severe physical stress (Chow, D., Rodriguez, L.V., 2013; Lee U. J., et al., 2017). The most probable mechanism of the influence of excess weight on the development and progression of genital prolapse is an increased intra-abdominal pressure, which causes weakness of the ligaments and fascial structures. Large-scale SWEPOP study (Swedish Pregnancy, Obesity, Pelvic floor), which included 9423 women, revealed that every unit which exceeds the normal body mass index increases the risk of symptomatic prolapse by 3% (Gyhagen M., et al., 2012). Moreover, Kuldish B.I. and colleagues showed in their work that the risk of

prolapse progression in obese patients compared with women with normal weight is increased in the cystocele, rectocele and apical prolapse by 48%, 58% and 69%, respectively (Kuldish B.I. et al., 2009). Chronic constipation and heavy physical activity also increase intra-abdominal pressure. The study of Woodman P.J. and colleagues showed that women who are engaged in hard physical labor at factories have a higher risk of POP development compared with office workers and housewives (Woodman P.J. et al., 2006). Also, undoubted risk factor for POP is previous surgical treatment such as hysterectomy, that lead to the development of the post-hysterectomy prolapse in 6-11%. (Moali P.A. et al., 2003; Barber M.D., 2016).

In order to understand the pathogenesis of a specific form of prolapse - anterior-apical, it is necessary to consider the mechanism of its development at the organ level. As already noted, damage of the support structures of the pelvic floor plays a key role in the development of POP. A significant contribution to the definition of these structures was made during dissections works of J.O.L. DeLancey, which described 3 levels of support (J.O.L. DeLancey, 1992). Level I is provided with the cardinal-uterosacral ligament complex, which attaches the upper part of the paracervix to pelvical walls. Level II is represented by endopelvic fascia. This fascia is subdivided into pubocervical, supporting the bladder and its cervix, and recto-vaginal, which prevents the anterior protrusion of the rectum. Level III of support consists of the lower third of the vagina, perineal membrane, levators and perineum. Damage of the level I leads to a prolapse of the apical compartment: uterus or vaginal vault. Defect of the level II, pubocervical fascia, leads to the prolapse of the anterior vaginal wall and bladder (cystocele), as well as the urethrocele. Injury of the integrity of level III leads to urethrocele and perineal defect. If the process of the apical prolapse development is quite universal, cystocele can occur by different mechanisms depending on the localization of the defects of the pubocervical fascia. Thus, 3 types of the pubocervical fascia defects are identified: lateral / paravaginal (in case of the detachment of fascia from arcus tendinous fascia pelvis); transverse / paracervical (when the fascia detaches from the paracervical ring); and central, occurring when the fascia is damaged between the bladder and the vagina (Maldonado P.A., Wai C.Y., 2016).

It should be noted that isolated forms of the prolapse occur rare. So, the work of Rooney K. and colleagues showed that advanced prolapse of the anterior vaginal wall was associated with the apical prolapse (Rooney K. et al., 2006). Summers A. and colleagues determined the position of the vaginal walls and pelvic organs according to MRI performed when the patients underwent Valsalva maneuver (Summers A. et al., 2006). The result of the given research became the conclusion, that half of the cases of anterior vaginal wall prolapse are caused by the apical prolapse. Lowder J.L. with colleagues conducted a simulation test aimed at restoring level I support by introducing gynecological speculum into the posterior vaginal fornix (Lowder J.L. et al., 2008). The authors noted that in 55% of cases, as a result of this test, the normal position of the anterior vaginal wall was restored in patients with the prolapse stage II or higher. Elliot C.S. and colleagues also note a significant close connection between cystocele and apical prolapse with strengthening of this connection at the advanced stage of prolapse (Elliot C.S. et al., 2013). The results of the study of Kenton K. and colleagues speak in support of the united pathogenesis of anterior and apical prolapse, which revealed that surgical treatment of POP without correcting the apical support level leads to the anatomical recurrence in 58% of patients one year after surgery (Kenton K., et al., 1999).

Thus, at the moment, the defect of the apical support, the I level according to DeLancey, plays the key role in the development of genital prolapse. It seems rational to distinguish the anterior-apical type of the POP based on the strong connection in the pathogenesis between the prolapse of the apical and anterior compartments. And this type of the genital prolase requires a simultaneous repair of the apical and anterior compartments.

1.3. The evolution of the treatment techniques for the anterior-apical prolapse

The problem of genital prolapse is known from the ancient times; therefore, the evolution of its treatment methods also has a long history. Soran of Ephesus, who lived in the 3rd century B.C., wrote a number of fundamental works on Gynecology, which

had a great significance up to the 17th century A.D. and were basic for studying. He also gave the first complete description of the uterus, proposed a number of conservative methods for prolapse treatment, considering removal of the uterus possible only in case of gangrenous complications (Emge L.A., Durfee R.B., 1996).

The first reliable mention of surgery performed for pelvic organ prolapse is associated with the name of Giacomo Berengario da Carpi. In 1521 he performed a hysterectomy by applying a ligature to a prolapsed uterus with its gradual tightening over several days, aiming at ischemic amputation of the organ (Lensen E.J.M. et al.,

2013). An important step in the study of genital prolapse was the description of cystocele in the 17th century by gynecologist Peyer from Switzerland. He noted that besides the uterus, the bladder as well can descend beyond the hymen (Lensen E. J.M. et al., 2013).

The next stage in the development of prolapse surgery refers to the beginning of the 19th century, due to the advances in anesthesiology, the emergence of new suture materials and the development of antiseptics, the ideas of which were proposed by Joseph Lister (Lister J. B., 1867). In 1813, Conrad Langenbeck performed the first total hysterectomy of the uterus for the treatment of prolapse using extraperitoneal approach, after which the patient survived (Walters M.D., Barber M.D., 2010). It is interesting, that in 26 years when the autopsy was performed, the posthysterectomy prolapse was diagnosed in this patient (Walters M.D., Barber M.D., 2010). In Russia, the first vaginal hysterectomy was performed by A.A. Kitter a little later in 1846 (Aylamazyan E.K.,

2014). In 1861 Chopin S. performed the first vaginal hysterectomy in America, in New Orleans, having presented the patient in a few months with the histological material in her hands in class of the School of Medicine in New Orleans (Downing K.T., 2012). The first success in the treatment of genital prolapse by vaginal hysterectomy led to the total spread of this technique. Already in 1937, at the annual meeting of American gynecological society, the hysterectomy was announced the predominant type of surgical treatment for POP (Baer J.L., 1937). By the middle of the 20th century, except the vaginal access the abdominal one was also introduced, performing both total hysterectomy and supracervical uterus amputation. However, the occurrence of patients

with post-hysterectomy prolapse became natural and this problem also needed to be solved. Thus, in 1957, McCall offers his technique of the cul-de-sac obliteration to prevent the vaginal vault prolapse and formation of enterocele in addition to the existing uterosacral vaginal wall suspension (McCall M. L., 1957). In the same year, Arthure and Savage described their approach for treatment of uterovaginal and post-hysterectomy prolapse, which consisted in the fixation of the uterus / cervical stump and the vaginal vault to the anterior longitudinal ligament of the sacrum with silk threads (Arthure H. G. E., Savage D., 1957). The authors reported 5-years' experience of this intervention. During the follow-up period, the recurrence rate was 10.4 (5/48). However, long before the promontory was chosen as the fixation point of the apical compartment, in 1892, Zweifel described his attempts to use the sacrotuberal ligament to fix the uterus or the vaginal vault (Downing K.T., 2012). This technique did not become widespread until Amreich, another surgeon from Germany, shared his experience of transgluteal and transvaginal sacrotuberal fixation in the 1950s (Barbalat Y., Tunuguntla H. S. G. R., 2012). Two other German gynecologists, Sederl and Richter, preferred the sacrospinous ligament to fix the vaginal vault instead of almost inaccessible sacrotuberous ligament (Downing K.T., 2012). Sacrospinous fixation gained widespread use all over the world and was named after its authors "Amreich-Richter technique".

It should be noted that in the 19th century a parallel direction in the prolapse surgery including reconstructive techniques was formed. There was a notion of vaginal "stretching", leading to the development of cysto- and rectocele, and therefore, it was considered rational to eliminate this defect without hysterectomy. So, the first operations for the treatment of vaginal wall prolapse with the excision of the excessive mucosa with the following reconstruction of its integrity appeared in the 1860s. Sims J.M., who made a great contribution into the development of Gynecology and Urogynecology and designed a number of tools for the diagnosis and treatment of gynecological pathology, described the method of treatment of the anterior apical prolapse in his monograph (Sims J.M., 1866). He noted that when the patient with prolapse strained, first of all the anterior vaginal wall descend, then the cervix, though

the use of gynecological speculum "simulated" the restoration of cystocele, the prolapse was eliminated. This patient underwent an excision of the "excess" part of the anterior vaginal wall which closure of the wound with silver sutures (Fig. 1).

Fig. 1. Anterior vaginal wall reconstruction, Sims J.M. (Taken from "Clinical notes of sterile condition". Sims J.M., 1866)

His contemporaries Emmet T.A. and Thomas T.G. also worked in the same direction, performing techniques of "denudation" of vaginal mucosa but they differed from each other in the shape of the excised fragments and the used instruments (Emge L.A., Durfee R.B., 1996). Researchers consider these interventions to be the progenitors of today's anterior colporrhaphy (Lensen E. J.M. et al., 2013). An extreme variant of such operations development was the creation of obliterating techniques. In 1877, Leon Le Fort proposed the technique of partial colpocleisis (Emge L.A., Durfee R.B., 1996). This technique was named after him and is used till present in elderly patients with high somatic risk, who are not recommended for reconstructive surgery (Barbalat Y., Tunuguntla H. S. R. R., 2012; Cho M.K., Moon J.H., 2017). Another reconstructive uterus-sparing technique, the uterine interposition, was also popular in the end of the 19th century. This intervention was proposed by Thomas Watkins for the treatment of the anterior-apical prolapse in 1898 (Barbalat Y., Tunuguntla H.S. G. R., 2012). This technique suggests to move the uterus retroperitoneally to a site between the bladder and the vagina. Uterine interposition was performed by a number of surgeons, including Schauta F. and Wertheim E. However, it was not widely used due to a range of limiting factors: high risk of septic peritonitis, possible complication in case of the necessity of

hysterectomy in the future, and the ability to perform only in postmenopausal patients (Wilson G.J., 1938). Despite the existence of numerous methods for the treatment of the anterior-apical prolapse by the beginning of the 20th century, further detailed study of the pelvic floor anatomy and improvement of the techniques were required due to the lack of their effectiveness for the anterior compartment. So, in 1909, Ahlfelt called the recurrent cystocele the only unsolved problem in aesthetic surgical gynecology (Cooke T.J.N.D., Gousse A.E., 2008). In the same year, White drew attention to the structures supporting the bladder and providing fixation of the vagina during the sectional study. He noted the lateral attachment of the vagina to the arcus tendinous fascia pelvis, the so-called white line, and suggested to perform the lateral paravaginal repair (White G.R., 1997). This technique was important because it was one of the first ideas about site-specific pelvic surgery; however, its relevance was evaluated only after several decades (Lensen E. J.M. et al., 2013). By the end of the 20th century, a lot of textbooks and manuals appeared where anterior colporrhaphy was obligatory presented as a method to correct cystocele. Nevertheless, as contemporaries of these published techniques evaluated them, they differed from each other though the same name (Weber A., Walters M., 1997; Barbalat Y., Tunuguntla H. S. G. R., 2012). In 1997 Weber and Walters described anterior colporrhaphy as an excision and plication of weakened and excessive vaginal tissues with various variants of incisions, layers of the dissection and suturing (Weber A., Walters M., 1997). They also determined the problem of the absence of terminological unity in the question of the vaginal wall layers and existence of a vaginal fascia. So, in published studies some surgeons sutured structures of the vaginal fascia, other - bladder wall. (Barbalat Y., Tunuguntla H. S. G. R., 2012; Choi K.H., Hong J.Y., 2014). Today, many publications indicate that Kelly was the first who described the anterior colporrhaphy in 1913 (Barbalat Y., Tunuguntla H.S. G. R., 2012; Choi K.H., Hong J.Y., 2014). However, in the original source there is information that Kelly proposed to put 2-3 sutures on the bladder neck tissue to treat urinary incontinence (Kelly N.A., 1913). In the described technique, the mucosa of the anterior vaginal wall was excised and the opposite edges were approximated by continuous catgut suture in 1 or 2 lays, i.e. he performed in a varying degree the previously

described "denudation" of the mucosa. The only difference was the goal of its performance: if the fathers of this technique gave priority to the elimination of the "stretched" mucosa, then Kelly wrote about "support of the bladder eliminating the dead space between it and the vagina". The recognition of the cystocele as one of the development factors for "relative" urinary incontinence led to the situation that in the middle of the 20th century operations technically similar to the colporrhaphy were performed in patients with urinary incontinence. So, the technique of "suturing the urethrotrigonal sphincter and fundus of the bladder" in the treatment of urinary incontinence was created by soviet obstetrician-gynecologist, urologist A.M. Mazhbitz and given in his monograph (Mazhbitz A.M., 1964). The author describes in detail the layers of dissection with the further plication of the muscles of the urethra and fundus of the bladder by single sutures and the subsequent repair of bladder fascia integrity resembling a "double-breasted vest". The anterior colporrhaphy still remains a traditional operation for the anterior vaginal wall prolapse, but the systematic review which included 40 randomized clinical trials showed that, up to date the standardization of this surgical technique remains unsolved (Harpen-Elenskaia K. et al., 2018). According to several authors, perhaps the lack of standardization and clear recommendations on the choice of patients for this intervention led to such a striking difference in the frequency of recurrences: from 3% to 70% (Porges R.F., Smilen S.W., 1994; Weber A.M., Walters M.D. et al., 2001). Another problem was the insufficient strength of the reconstructed tissues, which couldn't ensure reliable prolapse repair. The dissatisfaction of surgeons with the results of surgical treatment for cystocele led to the development of prosthetic surgery using biological and synthetic implants. The first reliable mention of the use of mesh material in pelvic floor surgery was dated 1955, when a tantalum implant, after previous experience of its use for SUI correction, was used in genital prolapse surgery (Goldberger M.A., Davids A.M., 1947; Moore J. et al., 1955). The first synthetic mesh implants for vaginal surgery were borrowed from general herniology: Marlex polypropylene mesh was used to reinforce the pubocervical fascia in the treatment for cystocele (Julian T.M., 1996). It is fair to note, that mesh implants were used much earlier in sacrocolpopexy, because the technique by this

moment existed for more than 30 years (Lane F.E., 1962). Infracoccigeal sacropexy, proposed by P. Petros in 1997, became a revolutionary technique in the reconstructive surgery of pelvic floor (Petros P.P.E., 1997). It supposed the "replacement" of the weakened uterosacral ligaments by mesh implant, fixed to the vaginal vault and conducted bilaterally through the ischiorectal space.

Thus, at the end of the 20th century, surgeons developed a number of techniques for the prevention and treatment of posthysterectomy prolapse, which formed the basis of methods for the repair of apical compartment, used till date. The low efficiency of native tissue repair in the treatment of the genital prolapse was revealed, and it was laid foundation for the development of mesh-based reconstructive surgery. Among the interventions proposed in the 19th century, the anterior colporrhaphy and colpocleisis remain currently important. According to the literature, the efficiency of partial and total colpocleisis with an average observation period of 12 months is quite high: 90-98% (DeLancey J.O., Morley G.W., 1997; Moore R.D., Miklos J.R., 2003; von Pechmann W.S. et al., 2003; Petcharopas A. et al., 2018). The analysis of patient satisfaction shows that the quality of life after the colpocleisis exceeds the preoperative level and can be compared to that after reconstructive surgery (Petcharopas A. et al., 2018). However, this intervention excludes the possibility of sexual life, and from 5.0 to 12.9% of patients regret to loss this possibility in the postoperative period (von Pechmann W.S. et al., 2003; Hullfish K.L. et al., 2007). Despite the effectiveness of the LeFort's operation, the average recurrence rate is 4.2%, according to the review that included 28 studies (Mikos T. et al., 2016). Prolapse recurrences after partial colpocleisis are a serious problem for the surgeon and include total recurrence, descendence in the area of the drainage channels and prolapse in the compartment not involved in the primary intervention. One of the rarely described variants of recurrence is perineal hernia, located in the area of the labia majora (Moroni R.M. et al., 2013).

In the 21th century, the process of the accumulation of the experience in previously developed methods that had taken their place in the surgery of genital prolapse was observed. Today, the repair of apical compartment is mainly achieved by

sacrocolpopexy (transabdominal rout) and transvaginally by sacrospinous fixation or with the use of mesh implants.

Sacrocolpopexy, first performed in traditional technique in 1962, for more than 50 years was considered the "gold standard" for the repair of apical compartment in the case of uterovaginal or posthysterectomy prolapse (Maher C. et al., 2013; Choi K.H., Hong J.Y., 2014). To achieve minimal invasiveness of surgical intervention, reduction of intraoperative blood loss, decrease of hospital stay duration laparoscopic access for this technique was developed in 1994 (Nezhat C.H. et al., 1994). Later, in 2004 the first robotic sacrocolpopexy was performed (Di Marco D.S. et al., 2004). Despite the fact that robotic sacrocolpopexy has shorter learning curve in comparison with the laparoscopic, it is associated with longer operation time and higher cost, according to several studies (Dungan J. S., 2012). In addition, the very existence of robotic equipment in the clinic limits the spread of this technique. Thus, among the abdominal methods, laparoscopic sacrocolpopexy is the most popular, which efficiency is 65% -94.4% (Ross J.W., Preston M., 2005; Sarlos D. et al., 2008; Ganatra A.M. et al., 2009). This technique, despite its high efficiency, is often accompanied by a number of intraoperative complications, such as: the risk of massive blood loss in 4.4% of cases (Nygaard I.E. et al., 2004), the development of obstructive defecation in the postoperative period with a frequency of 4.7-50,0% (Ross J.W., Preston M., 2005; Maher C.M. et al., 2011; Sarlos D. et al., 2014), as well as the erosion or mesh/suture extrusion - up to 10.5% (Nygaard I.E. et al., 2004; Nygaard I. et al., 2013), and in case of simultaneous hysterectomy - up to 27% (Culligan P.J. et al., 2002). Laparoscopic intervention may be contraindicated for somatically burdened patients due to the prolonged Trendelenburg position. Besides, it should be noted that the learning curve of laparoscopic sacrocolpopexy should amount at least 90 operations for reliable surgery with a low risk of intraoperative complications, to demonstrate positive anatomical result (Manodoro S. et al., 2011). But even considerable experience doesn't exclude the conversion to vaginal access due to the difficult access to the promontory and extensive adhesions, as the randomized study conducted by famous French surgeons showed (Lucot J.P. et al., 2018).

As already noted, the sacrospinous fixation is the most studied and widely used among the vaginal techniques. The review conducted among members of the International Urogynecological Association (IUGA) found out that 61% of them choose vaginal access for apical prolapse repair (Ghoniem G, Hammett J., 2015). At the same time, 59% choose sacrospinous fixation to correct the apical compartment. The traditional performance of the operation involves the fixation of one side of the vaginal vault (more often the right side) to the sacrospinous ligament, using either absorbable or non-absorbable sutures. The efficiency of this operation, according to the literature, reaches 96% (Hefni M.A., El-Toukhy T.A., 2006; Meuman N. et al., 2014). Besides the unilateral fixation, this technique is carried out in the form of bilateral fixation, as well as hysteropexy, which allows to perform uterine-sparing intervention (Kovac S. R., Cruikshank S. H., 1993; Zucchi A., et al., 2010). Already in 1993, data on successful pregnancies and deliveries after the performed sacrospinous hysteropexy were published (Kovac S. R., Cruikshank S. H., 1993). Specific complications of the sacrospinous fixation are recurrent cystocele, which occurs in 20-33% of patients due to deviation of the vaginal axis, which "opens" the anterior compartment (Karram M.M. et al., 1999; Morgan D.M. et al., 2007). As well the dyspareunia is revealed in 16% of patients, caused by a rigid fixation of the vaginal vault to the ligament and vaginal stenosis (Paraiso M.F. et al., 1996). Intraoperative complications associated with some technical elements of this method (performance of wide dissection in the area of the sacrospinous ligament to visualize it and stitch) include the risk of major bleeding, damage of the rectum and nerve endings (leading to buttock pain), vaginal strictures (Sze E.H., Karram M.M., 1997; Choi K.H., Hong J.Y., 2014; Alas A.N., Anger J.T., 2015). It is worth noting that, in comparison with the sacrocolpopexy, the learning curve for sacrospinous fixation turns out to be much shorter: the surgeon needs to perform about 20 interventions for the subsequent operation, to achieve positive anatomical result (Vitale S.G. et al., 2018). Today, an important issue is the economic component of the surgical interventions, taking it into consideration the superiority of the sacrospinous fixation becomes obvious. Comparing the cost of two procedures, Lua L.L. and colleagues made a choice in favor of the sacrospinous fixation, which was

more economically viable than the abdominal and laparoscopic sacrocolpopexy: $ 10.993 versus $ 12.763 and $ 13.647 respectively (Lua L.L. et al., 2017).

The high efficiency of sacrospinous fixation towards apical compartment, combined with the risk for developing a cystocele, resulted in the attempts to perform sacrospinous fixation combined with anterior colporrhaphy. However, the efficiency of this combination remains controversial. Thus, according to the study conducted by Brazilian surgeons, the adjunction of sacrospinous fixation with anterior colporrhaphy did not lead to a significant reduction in the cystocele recurrence rate (de Castro E.B. et al., 2016). The opposite results were published by Nager C.W. and colleagues who showed that the combination of anterior colporrhaphy and sacrospinous fixation improves anatomical results in comparison with the sacrospinous fixation alone (81% versus 73%, P = 0.02), especially, in case of advanced stages of preoperative cystocele (74% versus 57%, P = 0.02) (Nager C.W. et al., 2017).

As already noted, in attempts to improve the results of surgical treatment of cystocele in the late 20th century, the origin for the use of mesh implants was laid. The idea of infracoccygeal sacropexy proposed by P. Petros, later became known as posterior intravaginal sling (PIVS), showed promising results (79.0% - 93.2%), but was not widely used due to the described infectious complications and erosion rate (Farnsworth B.N., 2002; Chen H.Y. et al., 2011; Cosma S. et al., 2011; Capobianco G. et al., 2014). The polyfilament structure of the used implant (IVS, Tyco Healthcare), played a key role in the development of these complications. However, this technique was the "point of departure" for the creation of other implants and tools for their implantation, and the difference was that mesh arms were conducted not only through the ischiorectal space, but through the sacrospinous ligaments. Such systems were Apogee, Elevate (AMS), Prolift posterior, total (Ethicon) and analogues. The anatomical results of the use of these implants made them widely distributed. Till present, there are discussions about the effectiveness of synthetic implants for the correction of cystocele. Thus, according to the Cochrane database, the use of polypropylene mesh implants for the reconstruction of anterior compartment reduces the recurrence rate within 1-3 years from 45% to 13% (Maher C. et al., 2016). At that time,

in the already mentioned survey of the members of the International Urological Association, 81% of respondents called anterior colporrhaphy the best method for the correction of cystocele, while 80% preferred native tissue repair instead of the use of synthetic or biological implants (Ghoniem G., Hammett J., 2015). However, it should be noted that the possibility to use any technologies provided by health authorities often influences on the choice of a surgeon. The total spread of mesh technologies led to the accumulation of complications, predictably arising due to the absence of standards regulating the performance of these interventions. After the notification of FDA regarding the danger of the mesh implants usage in 2011, similar products ceased to exist in a number of countries (van Geelen J.M., Dwyer P.L., 2013). One of the most "ill fame" implants is Prolift (Ethicon), the complications of which implantation were described both in Russia and abroad (Popov A.A. et al., 2009; Jacquetin B. et al., 2010; Miller D. et al., 2011). For the last 10 years out of 20 years of the mesh systems existence a lot of studies on the complications of this type of surgery have been published. However, many of them require critical analysis. One of the well-known and frequently cited study dedicated to the use of mesh implants is the multicenter, randomized controlled study PROSPECT (Glazener C.M. et al., 2017). The authors of this study concluded that the use of synthetic mesh implants did not improve the surgical outcomes in efficiency, quality of life, postoperative complications, but more than every tenth patient had an implant-associated complication. In addition to the incorrectness of some quantitative data published in this study the information about the type of the used mesh is absent. The efficiency of the surgery was assessed only subjectively and also the experience of surgeons from the centers, included in the study, was questionable (on average, 10.4 patients from a center per year) (Futyma K. et al., 2017). While it is known that the operative technique and the surgeon's experience are the leading reasons for the development of implant-associated complications, and for the skill improvement, the urogynecologist needs to perform at least 30 interventions for prolapse annually (Miklos J.R. et al., 2016; Futyma K. et al., 2017). Official data indicating that the frequency of implant-associated complications from 2008 to 2010 in

the USA was only 0.67% (1503 cases registered per 225,000 operations) attract the attention also (MacDonald S. et al., 2016).

Thus, despite the prohibition to use synthetic implants in vaginal surgery in a number of countries, the validity of the declared fears is currently undergoing a review. However, these restrictive measures could not help influencing on the further evolution of mesh systems. Speaking about the reconstruction of the anterior-apical prolapse, it is necessary to note the Elevate Apical & Anterior system (AMS), representing a polypropylene mesh implant with 4 self-fixation anchoring arms: the anterior pair to the obturator complex, the posterior one - to the sacrospinous ligaments. This implant repairs I and II levels of support according to DeLancey due to a central part, that reinforce pubocervical fascia and the posterior arms, that restore uterosacral ligaments. At present the production of this implant is closed due to the change of the manufacturer's status, but it was widespread, that contributed to the accumulation of experience in its use. The effectiveness of the Elevate Apical & Anterior system at 12 months of follow-up management reaches 98%, and is within 89.0-90.0% during 24 months postoperatively (Rapp D.E. et al., 2014; Su T.H. et al., 2014; Castellani D. et al., 2017). The system with similar characteristics was manufactured in Russia, except that its implantation implies the trocar fixation, and four arms are conducted through the obturator complex - Pelvix anterior (Lintex, St. Petersburg). The efficiency of the repair of the anterior prolapse using this implant at 1.5 years of follow-up is 96.2% (Kubin N.D., Shkarupa D.D., 2014). At the same time, 2 (1.6%) cases of bladder damage during dissections were revealed intraoperatively; vaginal erosion in the place of implant fixation to the cervix with Prolen USP 0 was revealed in 1 (0.8%) patient in the postoperative period. OPUR (ABISS) is another popular system among "full-size" mesh implants for the repair of anterior-apical prolapse. This implant has 6 arms, the anterior and middle of which are conducted using the transobturator approach, the posterior - through the sacrospinous ligaments. The anatomical efficiency of the reconstruction using this system was 97% during 3 years of postoperative period (Guyomard A., Delorme E., 2016). This figure is promising, but the complications in the early postoperative period, such as hematomas, but also in the area between the

bladder and the anterior wall of the vagina (4-11.6%), and difficult urination (28%) indicate a relatively wide dissection and potential redundancy of implant size and the number of its fixating arms (Nikitin A.N., Ishchenko A.I., 2016; Guyomard A., Delorme E., 2016).

The fight against implant-associated complications stimulated the development of a new direction in the mesh-based pelvic reconstructive surgery: minimizing of the mesh size and reduction of its fixation points. The UpHold system (Boston Scientific) became one of the representatives of this direction, this is an implant with quite a wide central area, fixing it to the cervix and two arms fixing to the sacrospinous ligaments. This implant has proven to be highly efficient in restoring the apical and anterior compartments (94-97%), however, the frequency of vaginal erosion and extrusion of the implant, requiring surgical treatment remains quite significant 1.7-6.5% (Jirschele K. et al., 2015; Altman D. et al., 2016). The next step to the reduction of the size of the implants was associated with the use of mesh tapes with the size similar to TVT for the treatment of the apical prolapse. In 2016, the results of using the monofilament polypropylene sling I-STOP (CL Medical, Winchester, MA) and UroSling - 1 (Lintex, St. Petersburg) as an apical sling for bilateral sacrospinous fixation were published independently of each other. Alas A.N. and colleagues reported 100% efficiency of I-STOP sling for the treatment of post-hysterectomy prolapse 6 months of postoperative follow-up (Alas A.N. et al., 2016). In fact, the bilateral sacrospinous ligament fixation of the apical compartment using the tape is equivalent to the already mentioned posterior intravaginal sling. The important differences are the mandatory fixation of the implant to the sacrospinous ligaments, and the type of implant (type I according to the Amid classification) that is used. UroSling-1 was used to repair not only post-hysterectomy, but also uterovaginal prolapse (Shkarupa D.D. et al., 2016). An important difference between the performed technique and the foreign analogue was a combination of the apical compartment restoration using synthetic tape and the pubocervical fascia reconstruction by an original technique of subfascial colporrhaphy. A combination of mesh surgery and native tissue repair was reflected in the name of this technique, it was named "hybrid technique" (Kubin N.D. et al., 2017). The effectiveness

of the hybrid surgical reconstruction of anterior-apical prolapse at 12 months of follow-up was 97% with the absence of vaginal erosion. However, as it is typical for the anterior colporrhaphy, the choice of the types of suture materials for the repair of pubocervical fascia was not determined clearly, while the subfascial approach of suturing allowed to use non-absorbable sutures as well (Shkarupa D.D. et al., 2016). In view of the potential risks of suture extrusion and vaginal erosion the feasibility of the latter remains in question.

1.4 Suture materials for the approximation of endopelvic fascia structures

Endopelvic fascia reconstruction is traditionally performed by the repair of its defects using suture materials. Thus, the anterior colporrhaphy proposed in the 19th century was for a long time the method of choice for cystocele repair (Rock J.A., Jones H.W., 2003; Kelly H.A., 1913). However, the recurrence rate reaching 40% according to a range of studies, led to the necessity to use mesh implants, which increased the effectiveness of surgical interventions up to 93-100% (Weber A.M. et al. 2001; Sand P.K. et al., 2001; Nguyen J.N. et al., 2008; Milani R. et al., 2005; de Tayrac R. et al., 2007). Synthetic mesh implants showed high reliability of the repair of fascia defects in both general herniology and in the treatment of pelvic organ prolapse in comparison with native tissue repair (Luijendijk R.W. et al., 2000; Maher C. 2013; Kontogiannis S. et al., 2016). The reverse side of the coin was the implant-associated complications, which forced the surgeons to go back to traditional techniques (Iglesia C.B. et al., 2010; Goldstein H.B. et al., 2007).

The efficiency of native tissue repair may depend on the surgical technique and the surgeon's experience, as well as on the correct choice of the suture material for appropriate intervention. After all, it is the suture material that resists intra-abdominal pressure until a reliable scar is formed (Petros P. E. P., 1998). Suture material used in pelvic reconstructive surgery is a "mini-implant" or foreign body that remains in the patient's tissues (Evtushenko N.G., 2014). The requirements for suture materials were first formulated in the 19th century. So, N.I. Pirogov in the "Principles of Military

Surgery" wrote: "... the best suture material is that, which: a) causes the least irritation in the puncture channel, b) has a smooth surface, c) doesn't absorb wound liquid, doesn't swell, does not provoke fermentation, doesn't become a source of infection, d) is enough solid and ductile, but thin and not bulky, and doesn't stick to the walls of the puncture. Here is the ideal suture" (Gromova A.L. et al., 2011).

The important characteristics of the suture material used in vaginal surgery are the lack of capillarity. Capillarity is the ability of suture material to absorb and hold liquid in the pores as a result of the surface tension force (Egiev V.N. et al. 2001). Exactly these results determine the infection resistance of the material in a greater degree. These characteristic (absence of capillarity) is specific for the monofilament or pseudo-monofilament sutures.

An important characteristic is also the ability to biodegradation, in accordance with which the absorbable and non-absorbable sutures are identified. Concerning the fixation of the implant to the pelvic ligaments in the case, the choice of suture material is obvious - non-absorbable sutures are the most reliable. It should be noted that in these cases there is no contact of the vaginal mucosa with the suture material, and therefore the risk of erosion and suture extrusion does not exist. Speaking of native tissue repair, the advantage of non-absorbable sutures over sutures with long absorbtion period for the repair of apical compartment was also demonstrated with the example of fixation to the sacrouterine ligaments (Chung C.P. et al., 2012). The repair of endopelvic fascia is not so clear. First, the mucosa and fascia are close to each other. Secondly, the overwhelming majority of women suffering from genital prolapse, has an age-related estrogen deficiency. The latter influences on the quality of vaginal mucosa - it is thin, atrophic, which creates an additional risk of erosion.

Today, the issue of suture material choice for the reconstruction of endopelvic fascia is not sufficiently highlighted. In 2013, the work on the role of additional suture, fixing the repaired pubocervical fascia to the cardinal ligaments with colporrhaphy, in order to improve the efficiency of the surgery, was published (Zebede S. et al., 2013). The authors compared the outcomes of the use of non-absorbable suture (prolene) and absorbable one (vicryl) as an additional suture. They concluded that an additional

stitches, which fixed the endopelvic fascia to the apical compartment support with prolene led to a better anatomical correction in comparison with the use of vicryl. However, the use of non-absorbable sutures was associated with suture extrusion in 6.5% of patients, which required the excision of these threads. At the same time, there was no difference between the groups in the occurrence of dyspareunia de novo. According to Luck A.M. and colleagues, the use of non-absorbable suture material in posterior colporrhaphy and sphincteroplasty was also associated with a higher rate of suture extrusion, compared with the absorbable sutures: 31.3% versus 9% (Luck A.M., et al., 2005). Goldstein H.B. and colleagues revealed in their study that the risk of excessive granulations and infectious processes after surgery for genital prolapse is associated with the structure of suture material, its complexity, regardless of the biodegradation (Goldstein H.B. et al., 2007). There were no statistically significant differences in prolapse recurrence in the groups with absorbable and nonabsorbable sutures. However, it should be noted that the study was retrospective and crossover: patients after uterosacral ligaments plication, abdominal sacrocolpopexy, posterior colporrhaphy, perineoplasty, etc. The analysis of specific types of surgical interventions was not carried out. In 2016, authors published the study aimed to identify the influence of the suture absorption rate on the outcomes of anterior and posterior colporrhaphy (Bergman I. et al., 2016). In the first group, the surgery was performed using fast absorbable sutures (Vicryl, Polysorb, Dexon), in the second - with slowly absorbable ones (PDS, Maxon). According to the study, the lower percentage of symptomatic recurrence after anterior colporrhaphy was detected in the group with slowly absorbable materials. However, in the urgency decreasing and increasing of sexual activity was in a greater degree observed in patients who underwent reconstruction of the pubocervical fascia with fast absorbable sutures. No differences in the results of posterior colporrhaphy between two groups were found. In a review published in 2018 devoted to the analysis of anterior colporrhaphy technique, the authors of 27 studies used 6 types of suture materials, including both absorbable and non-absorbable fibers (Harpen-Elenskaia K. et al., 2018). Interesting, that the authors of 13 other randomized clinical trials didn't reflect the type of the used suture material in their articles.

Thus, the question of choice of suture material for the reconstruction of endopelvic fascia remains actual up to now. The lack of researches on this issue and the ambiguity of the results lead to the fact that the choice of material continues to be based on the individual preferences of surgeon (Bergman I. et al., 2016; Harpen-Elenskaia K. et al., 2018). While the anterior colporrhaphy remains one of the most "mysterious" operations in pelvioperineology, which does not have standardization both in the technique and in the choice of suture material.

1.5 Efficiency and safety of hysterectomy for the treatment of anterior-apical prolapse

Today, according to Russian and foreign specialists, hysterectomy is one of the most common gynecological operations (Humalajarvi N. et al., 2014). According to V.I. Krasnopol'sky uterus extirpation is 38.2% of the total number of gynecological operations in the Russian Federation (Krasnopol'sky V.I. et al., 2010). In the United States in 2010, more than 433,000 hysterectomies were performed (Wright J.D. et al., 2013). The significant part of these interventions is performed on benign conditions, including genital prolapse. According to Whiteman M.K. and colleagues in the period from 2000 to 2004 the genital prolapse was in 3rd place (17.4%) after leiomyoma and endometriosis among the indications for hysterectomy (Whiteman M. K., et al., 2008). Although, even in the middle of the 20th century, surgeons concluded that hysterectomy couldn't be performed as an independent intervention for POP (Arthure H. G. E. E., Savage D., 1957).

According to a number of researches, hysterectomy relieves patients of the disturbing symptoms effectively and improves their quality of life (Kjerulff K.H. et al., 2000; Humalajarvi N. et al., 2014). However, the potential complications that may be associated with this intervention, such as urinary incontinence, changes in sexual life and an earlier onset of menopause, are worrying (Whiteman M. K. et al., 2008). During the hysterectomy, the structures supporting pelvic organs and maintaining the mechanisms for urine retention are damaged, as well as nerve endings innervating them. Al this may lead to the development of posthysterectomy prolapse and functional

disorders of the bladder and bowel (Radzinsky V.E., 2006; Podzolkova N.M. et al., 2014; Peter P., 2016; Dobrohotova, Y.Y., Ilina I.Yu., 2017; Brown J.S. et al., 2000; Roovers J.P., Lakeman M.M., 2009).

According to the literature data, the incidence of posthysterectomy prolapse varies widely from 0.2% to 45% (Flynn B.J., Webster G.D., 2002; Dallenbach P. et al., 2008; Nyyssonen V. et al., 2013). The study conducted at the Mayo Clinic showed that in 693 patients who applied for a vaginal vault prolapse, the period from hysterectomy to the development of prolapse averaged 15.8 years (Webb M.J. et al., 1998). Dallenbach P. and colleagues revealed that the risk of surgical treatment for posthysterectomy prolapse is 4.7 times higher if the previous extirpation was performed for the prolapse, and 8 times higher if the prolapse stage was II or higher (Dallenbach P. et. al., 2007).

The effect of hysterectomy on the function of the lower urinary tract is ambiguous. Hanley H.G. in 1969, for the first time drew attention to the appearance of functional disorders of the urinary system in patients undergoing hysterectomy. He noted the occurrence of frequent urination, dysuria, and in some cases urgency and urinary incontinence after hysterectomy (Hanley H.G., 1969). Milsom I. and colleagues studying the risk factors for the development of SUI, revealed that the incidence of this pathology in patients undergoing hysterectomy is higher than in women who did not undergo this intervention: 20.8% versus 16.4% (Milsom I. et. al., 1993). However, in the systematic review published in 2000, it was concluded that extirpation of the uterus increased the risk of urinary incontinence by 60% in women older than 60 years, without having a significant effect on the function of the lower urinary tract in younger patients (Brown J.S. et al., 2000). The study conducted by Farquhar S.M. and colleagues, showed that frequent urination and nocturia significantly reduced within 5 years after hysterectomy, while the incidence of stress or urge incontinence was not increased in the postoperative period (Farquhar C.M. et al., 2008).

As already mentioned, sacrocolpopexy is considered as "gold standard" for the correction of apical prolapse in sexually active young women which efficiency is more than 90% (Lucot J.P. et al., 2018; Davidson E.R.W. et al., 2018). The traditional

technique of this intervention assumes the subtotal hysterectomy. Theoretically, during the subtotal hysterectomy supporting structures of the pelvic floor are damaged in less degree, which might reflect on the rate of the pelvic organ dysfunction in the postoperative period. However, according to a large comparative study on objective and subjective assessment of the genital prolapse and urinary incontinence after the total and subtotal hysterectomy during 14 years of control, no differences between the groups were found (Andersen L.L. et al., 2015). Aleixo G.F. and colleagues carried out the systematic review and meta-analysis of publications which compared the influence of the total and subtotal hysterectomy on symptoms of the pelvic floor, and revealed that stress urinary incontinence develops more often (p <0.04) after supravaginal uterine amputation: 52.5% versus 44.3% (Aleixo G.F. et al., 2018). No statistically significant differences in the incidence of urgency, urge urinary incontinence, genital prolapse, as well as constipation and fecal incontinence were revealed.

The hysterectomy in young patients, compared with postmenopausal women, can lead to the development of post-hysterectomy syndrome. As it is known, post-hysterectomy syndrome is a specific complex of symptoms, which develops after hysterectomy preserving one or two ovaries, characterized by psychovegetative and metabolic disorders (Kulakov V.I. et al., 2009). One of the most common points of view on the etiology of this condition is the idea of developing hypoestrogenia due to impaired ovarian blood flow after the uterine artery is cut (Makarov O.V. et al., 1998; Makarov O.V. et al., 2000; Fateeva A.S., 2016). However, there are the conceptions that the uterus itself can participate in hormonal homeostasis and contribute to the reduction of FSH via the feedback mechanism. Similar conclusions were made during the conducted animal experiments (Biro J.C., Eneroth P., 1990). The data on the increase of FSH in both women who underwent a hysterectomy and patients who underwent endometrial ablation within 1 year after surgical treatment, speak in favor of the theory of the endocrine function of endometrium (Derksen J. G. et al., 1998). The study of Farquhar and colleagues showed that on average menopause in women after a hysterectomy with preserved ovaries occurs 3.7 years earlier than in the control group (Farquhar C.M. et al., 2005). While in patients with unilateral ovariectomy it occurs 4.4

years earlier than in patients who underwent a hysterectomy without removal of appendages. According to the researches, during the first year after the surgery, neurovegetative and psychoemotional disorders prevail in women, but endocrine and metabolic disorders, changes in lipid and carbohydrate metabolism occur during the next 4 years (Podzolkova N.M. et al. 2014; Glazkova O.L., Poletova T.N., 2016). According to Makarov O.V. and colleagues, the removal of the uterus without ovariectomy or with unilateral adnexectomy, contributes to the aggravation of arterial hypertension (Makarov O.V. et al. 1998). In case if woman had a hysterectomy before the menopause, the risk of a debut of high blood pressure increased.

It should be noted, that at the moment patients participate actively in the treatment and often their readiness and acceptance of a surgical intervention plays an important role in the planning of the surgery. Many women want to preserve their uterus, guided by fears to decline sexual relations after surgery, face the changes in perception of the spouse, and also considering this organ as one of the components of femininity (Neuman M., Lavy Y., 2007; Korbly N.B. et al., 2013; Meriwether K.V. et al., 2018). According to Hartmann K.E. and colleagues, hysterectomy leads to a change in the sexual life of patients, they also noted the occurrence of dyspareunia de novo in 1.9% of women who underwent surgery (Hartmann K.E. et al., 2004). However, in later papers, the researchers did not mention the negative impact of this surgery on the nature of the sexual aspect of patients' lives (Farquhar C.M. et al., 2008). It is necessary to notice that in view of "rejuvenation" of this pathology, there are patients with advanced form of the prolapse, requires surgical intervention, who plan pregnancy and delivery in future. In this case, hysterectomy is unacceptable. Korbly N.B. and colleagues conducted an inquiry among patients planning surgical treatment for POP, which revealed that in case of equal effectiveness of hysterectomy and uterus-sparing technique, 36% of women refuse the removal of the uterus (Korbly N.B. et al., 2013). Moreover, if the efficiency of the uterine-sparing surgery will be higher, then 46% of patients will choose it, and 22% will refuse the hysterectomy even in case if the expected efficiency will exceed such with uterus-sparing technique. Over the past twenty years, the number of papers devoted to the uterus-sparing techniques for POP

treatment increased. Meriwether K.V. and colleagues published a systematic review with a meta-analysis, which included 53 articles comparing the efficiency and outcomes of uterine-sparing and hysterectomy techniques: vaginal hysteropexy with the use of mesh implants, sacrocolpopexy, sacrohysteropexy, and uterosacral fixation etc. (Meriwether K. V. et al., 2018). The authors of the review made a conclusion that the uterus-sparing techniques can be offered to the patients who need to repair the apical compartment, as far as in this case the operation time, blood loss and the risk of vaginal erosion using mesh implants are reduced in comparison with the similar techniques which imply the hysterectomy. At that, early postoperative outcomes do not differ much from those when the uterus is removed.

***

Thus, the evolution of the technologies of the anterior-apical prolapse treatment covered a long way from the hysterectomy to the minimal-mesh procedures combined with the native tissue repair. To date, the great demand for uterus-sparing POP surgery in regard to reduce intra- and postoperative morbidity, individual approach to patient, preventive orientation of the treatment and economic feasibility become obvious.

Chapter 2. THE MATERIALS AND METHODS OF THE RESEARCH

2.1. The materials and methods of the experimental research

The experimental part of the study was conducted in the vivarium No. 1 of the Department of Operative Surgery, North-Western State Medical University named after I.I. Mechnikov, and at the Department of Morbid Anatomy, Leningrad Regional Clinical Hospital, as well as in the research and production laboratory LLC Lintex (Saint-Petersburg) with direct involvement of the author.

2.1.1. In vitro study of the mechanical properties of the suture material

When using surgical sutures for tissue approximation, the surgeon is guided by the strength properties declared by the manufacturers of these materials. One of the important aspects is the biodegradation ability, as well as strength, determined by the breaking strength of the thread at different periods of absorption. The peculiarity of tensile strength measurement is that the manufacturer identifies it for threads tied in a simple knot. The strength properties for the threads using for continuous sutures, like those which are used in colporrhaphy, remain unknown.

Four samples of suture materials were taken to analyze tensile strength in vitro and in vivo. These samples were representatives of the most common types of materials in modern surgery, differing in chemical composition, structure and period of biodegradation. A woven polyester thread with a fluoropolymer coating (pseudomonofilament thread), a coated woven polyglycolide thread, a polydioxanone monofilament and polyglecaprone monofilament threads (Tables 1,2) were researched.

Table 1 - Samples of suture material.

Sample Material Thread structure Trade Name USP

№ 1 Polyester with fluoropolymer coating Complex coated (pseudomonofilament) Ftorex 2

№ 2 Polydioxanone Monofilament Monosorb 2