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Идёт набор NCT06559085

Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse

Без фазы С лечением Posterior Laparoscopic Lateral Laparoscopic Rectopexy Complete Rectal 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: Laproscopic posterior mesh rectopexy (Wells or LPMR), Laparoscopic lateral mesh rectopexy (Orr-Loygue).
Кому может быть актуально
Состояния в реестре: Posterior Laparoscopic, Lateral Laparoscopic, Rectopexy, Complete Rectal Prolapse. Базовые параметры: 18 лет — 75 лет · Все.
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
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Обзор

Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy

Подробное описание

Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.

Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.

The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.

The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery

Вмешательства

  • Процедура Laproscopic posterior mesh rectopexy (Wells or LPMR)
    After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported
  • Процедура Laparoscopic lateral mesh rectopexy (Orr-Loygue)
    This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study

Первичные конечные точки

  • Operative time [Срок оценки: Until the conclusion of the surgical procedure]
  • Intraoperative injuries [Срок оценки: Until the conclusion of the surgical procedure]
Вторичные конечные точки (3)
  • Improving of symptoms [Срок оценки: 28 days after surgery]
  • Recurrence rate [Срок оценки: 28 days after surgery]
  • Complications [Срок оценки: 28 days after surgery]

Критерии участия

Критерии включения

  • Age from 18 to 70 years.
  • Both sexes.
  • Patients with complete rectal prolapse.

Критерии исключения

  • Unfit for surgery
  • Impaired coagulation profile
  • Contraindication of laparoscopy

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
  • Assiut university — Asyut

Идентификаторы

NCT: NCT06559085 · 04-2024-100197

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗