Идёт набор NCT07375147

Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

Без фазы С лечением Rectocele; Female

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: Stapled Transanal Rectal Resection, Stapled Transvaginal Rectal Resection.
Кому может быть актуально: Состояния в реестре: Rectocele; Female. Базовые параметры: от 18 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 →

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Официальное название

Outcomes of Transanal Versus Transvaginal Rectal Resection for Anterior Rectocele: A Randomized Controlled Trial

Обзор

Female patients presenting with obstructed defecation syndrome due to anterior rectocele will be screened according to inclusion and exclusion criteria. Eligible patients will undergo clinical assessment and appropriate investigations including defecography. After informed consent, patients will be randomized into two groups: Stapled Transanal rectal resection or Stapled Transvaginal rectal resection. Improvement in obstructed defecation symptoms and postoperative complications will be compared between the two groups.

Подробное описание

This is a randomized controlled trial aims to compare the clinical outcomes of Stapled Transanal versus Stapled Transvaginal rectal resection in female patients with obstructed defecation syndrome (ODS) caused by anterior rectocele.

Female patients presenting to the outpatient colorectal clinic with symptoms of obstructed defecation syndrome will be screened for eligibility according to predefined inclusion and exclusion criteria. All eligible patients will receive a detailed explanation of the study objectives, procedures, potential benefits, and risks. Written informed consent will be obtained prior to enrollment.

A comprehensive preoperative evaluation will be performed for all participants, including detailed medical history, physical and anorectal examination, and appropriate investigations including defecography to confirm the diagnosis and assess the severity of rectocele.

Enrolled patients will be randomly assigned in a 1:1 ratio into one of two intervention groups. Group A will undergo stapled Transanal rectal resection, while Group B will undergo stapled transvaginal rectal resection. All surgical procedures will be performed by experienced colorectal surgeons.

Primary outcome measures will include improvement in obstructed defecation symptoms as assessed by Cleveland Clinic Constipation (CCC) score. Secondary outcomes will include length of hospital stay, operative time, postoperative pain score, postoperative continence state, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and postoperative complications.

Вмешательства

Процедура Stapled Transanal Rectal Resection
Patients were placed in the lithotomy position. Using the trans-anal approach, rectocele was done using PPH circular staplers. A circular anal dilator (CAD) was inserted into the anus and sutured into position. Three full-thickness prolene 2/0 sutures were positioned at the anterior, left anterior lateral, and right anterior lateral locations, approximately 4 cm above the dentate line. At the posterior aspect, a tongue depressor was placed into the CAD groove to protect the posterior rectal wall
Процедура Stapled Transvaginal Rectal Resection
The patient in the lithotomy position. Anal dilatation was performed. A transverse incision was made in the mucocutaneous border of the vaginal introitus; the posterior vaginal wall was dissected and separated from the anterior rectal wall up to the posterior fornix. Dissection was extended laterally to the maximum length of the rectocele. Two Babcock clamps were applied longitudinally to the rectocele, and the stapler was fired to divide the rectocele. Partial thickness stitches were applied ov

Первичные конечные точки

Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score [Срок оценки: Up to 6 months postoperatively]

Вторичные конечные точки (11)

Operative time [Срок оценки: During surgery]
Hospitalization period [Срок оценки: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery]
surgical site infection [Срок оценки: Up to 6 months postoperatively]
Time for wound Healing [Срок оценки: Up to 6 months postoperatively]
Postoperative bleeding [Срок оценки: Up to 6 months postoperatively]
Postoperative fecal incontinence [Срок оценки: Up to 6 months postoperatively]
Postoperative urine retention [Срок оценки: Within 48 hours postoperatively]
Pain intensity [Срок оценки: At day 1 and day 7 postoperatively]
Sexual Function in both groups [Срок оценки: Up to 6 months postoperatively]
Postoperative anal stenosis in both groups [Срок оценки: Up to 6 months postoperatively]
Postoperative rectovaginal fistula in both groups [Срок оценки: Up to 6 months postoperatively]

Критерии участия

Критерии включения

Adult female patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm on straining with failure of conservative management.