Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures for Management of Neuropathic Fecal and Urinary Incontinence in Children
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
- Early as Occurrence of leak, abscess formation, intestinal obstruction, appendicular necrosis, fecal and urinary fistula formation.
- 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
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
Mohammad Daboos
Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.
Al-Azhar University
