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Идёт набор NCT07596498

Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy

Без фазы С лечением Apical Prolapse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Laparoscopic Pectopexy, Laparoscopic Sacrocolpopexy.
Кому может быть актуально
Состояния в реестре: Apical Prolapse. Базовые параметры: 40 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy in Treatment of Apical Prolapse

Обзор

Pelvic organ prolapse, particularly apical prolapse, is a common condition among aging women, and laparoscopic sacrocolpopexy is considered the standard surgical treatment due to its high anatomical success. However, it poses technical challenges and risks related to sacral dissection. Laparoscopic pectopexy, a newer technique using the iliopectineal ligament for mesh fixation, offers a safer anatomical route with shorter operative time and fewer complications. The previous studies evaluate the sacrocolpopexy and pectopexy are all retrospective. This study is prospective randomized controlled study that adds Comparison on the success rate and learning curve of pectopexy versus sacrocolpopexy .

Подробное описание

Pelvic organ prolapse (POP), particularly apical prolapse, is a prevalent condition that significantly impairs the quality of life in aging women, with a global prevalence ranging from 20% to 65% among those over 50 years of age. It involves the downward displacement of the vaginal apex, uterus, or vaginal vault, and is frequently accompanied by urinary, bowel, and sexual dysfunction. Despite conservative measures, many women with symptomatic POP ultimately require surgical correction to restore pelvic anatomy and function.

Multiple surgical techniques have been developed for apical suspension, including transvaginal approaches (e.g., sacrospinous fixation, high uterosacral ligament suspension), transabdominal techniques, and laparoscopic modalities. Among laparoscopic approaches, sacrocolpopexy (LSC) has long been considered the gold standard due to its superior anatomical outcomes compared to native tissue repair or vaginal mesh-based procedures.

However, it demands advanced laparoscopic skills, has a steep learning curve, and carries a risk of complications such as presacral hemorrhage, mesh erosion, defecation dysfunction, and sacral osteomyelitis.

Laparoscopic sacrocolpopexy involves dissection at the sacral promontory and mesh fixation to the anterior longitudinal ligament. Although it provides excellent long-term anatomical support-with reported objective success rates between 78% and 100%-it is associated with longer operative time and potential injuries to the ureter, bowel, or vessels. Furthermore, the anatomical challenges posed by the sacral promontory, especially in obese patients, can hinder operative safety and efficiency.

Laparoscopic pectopexy, first described by Banerjee and Noé in 2011, is an emerging alternative technique in which the mesh is bilaterally anchored to the iliopectineal (Cooper's) ligaments. This anterior fixation avoids dissection near critical retroperitoneal structures and preserves the posterior pelvic space, thereby reducing the risk of defecation disorders and nerve injury. Pectopexcy an emerging technique offers a potential alternative for apical prolapse repaire .this study aims to compare its efficacy \&safety with conventional procedures.

Вмешательства

  • Процедура Laparoscopic Pectopexy
    to evaluate the effectiveness and learning curve of laparoscopic pectopexy in comparison with laparoscopic sacrocolpopexy for the treatment of apical prolapse performed by the same surgeon.
  • Процедура Laparoscopic Sacrocolpopexy
    Laparoscopic Sacrocolpopexy

Первичные конечные точки

  • Pain Assessment [Срок оценки: 24 Hours]
  • Number of participants treated [Срок оценки: 6 Months]

Критерии участия

Критерии включения

  • Patients diagnosed with uterine prolapse with POP-Q stage ≥ III.
  • Patients diagnosed with vault vaginal prolapse with POP-Q stage ≥ III.

Критерии исключения

  • Patients who refuse to participate in the study.
  • Patients who have isolated anterior or posterior vaginal wall prolapse.
  • Women who are pregnant or lactating.
  • Patients with severe comorbidities, including: Serious heart, liver, kidney, or blood diseases or any condition preventing them from tolerating surgery.
  • Women with a desire to conceive.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Ain Shams University Hospital — Cairo

Идентификаторы

NCT: NCT07596498 · Apical Prolapse

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗