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临床试验/NCT07206719
NCT07206719已完成不适用

Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures for Management of Neuropathic Fecal and Urinary Incontinence in Children

Mohammad Daboos1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Surgical Outcomes

研究概览

简要总结

This was a prospective study. The study period was from January 2022 to July 2025. The study included 30 patients suffering from combined fecal and urinary incontinence submitted for concurrent Malone Antigrade continent Enema and Mitrofanoff procedures and evaluated regarding intraoperative difficulties, post-operative complications, functional results and patient's quality of live improvements.

详细描述

-This was a prospective study, at Al-Azhar university hospitals. The study period was from January 2022 to July 2025. The study included all patients suffering from combined fecal and urinary incontinence after failure of all trials of non-surgical managements.

The investigator aimed to study the safety and surgical oucomes of the management of fecal and urinary incontinence in children by concurrent Malone Antigrade Continent Enema and Mitrofanoff procedures regarding intraoperative difficulties, post-operative complications, functional results and patient's quality of live improvements.

  • They submitted for surgical management by concurrent Malone Antigrade Continent Enema (MACE) and Mitrofanoff procedures at the same operative sitting.
  • the outcomes measures included:--Intraoperative parameters including length of appendix, operative time, and intraoperative complications (bleeding, visceral injury, ureteric injury, appendicular vascular affection).
  • Postoperative parameters
  1. Early as Occurrence of leak, abscess formation, intestinal obstruction, appendicular necrosis, fecal and urinary fistula formation.
  2. Late as Stricture formation and requirement of secondary procedures as dribbling of urine through the urethra or soiling of stool. Also function result as volume of required colonic washout fluid, frequency of the Malone stoma catheterization, Frequency of Mitrofanoff catheterization, urine volume and Patient quality of life utilizing QOL score 9
  • We started Mitrofanoff stoma catheterization after three weeks of procedure. and Started Malone ante grade continent enema after one month. The volume of saline used for washout was calculated according to body weight 20ml/kg. Outpatient clinic visits every week then at 3, 6 and 12 months postoperatively for evaluation of post-operative complications, function outcome and patient QOL score

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

surgical management by concurrent Malone Antigrade Continent Enema (MACE) and Mitrofanoff procedures at the same operative sitting, for patients suffered from combined fecal and urinary incontinence due to neuropathic etiology.

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •all patients suffering from combined fecal and urinary incontinence due to neuropathic etiology
  • •failure of all trials of non-surgical managements

排除标准

  • •The patients responding to medical treatments,
  • •patients with previous appendectomy,
  • •patients with marked reduction of bladder capacity,
  • •patients with Brain affection (Cerebral palsy, etc..)
  • •and patients with isolated fecal or urinary incontinence

研究组 & 干预措施

MACE and Malone

Experimental

patients suffering from combined fecal and urinary incontinence due to neuropathic etiology, after failure of all trials of non-surgical managements. They submitted for surgical management by concurrent Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures at the same operative sitting

干预措施: Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures (Procedure)

结局指标

主要结局

Surgical Outcomes

时间窗: 6 months

Complication rate 1-Early as Occurrence of leak, abscess formation, intestinal obstruction, appendicular necrosis, fecal and urinary fistula formation. 2\. Late as Stricture formation and requirement of secondary procedures as dribbling of urine through the urethra or soiling of stool

次要结局

  • Patients Quality Of Life post operatively(6 months)

研究者

发起方
Mohammad Daboos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad Daboos

Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.

Al-Azhar University

研究点 (1)

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