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临床试验/NCT07375147
NCT07375147招募中不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
1
主要终点
Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Patients with Slow-transit constipation
  • Patients with rectocele of < 3 cm on straining
  • Patients with complete external rectal prolapse
  • Evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD)
  • Previous rectal surgeries
  • Inability for lifestyle change postoperatively
  • Previous surgeries for anterior rectocele

研究组 & 干预措施

Stapled Transanal Rectal Resection

Active Comparator

Patients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele

干预措施: Stapled Transanal Rectal Resection (Procedure)

Stapled Transvaginal Rectal Resection

Experimental

patients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele

干预措施: Stapled Transvaginal Rectal Resection (Procedure)

结局指标

主要结局

Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score

时间窗: Up to 6 months postoperatively

Compare Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score. CCC score ranges from 0 to 30. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms )

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abdelaal

Lecturer

Cairo University

研究点 (1)

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