NCT07206719

Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mohammad Daboos · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

-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

Conditions

• Fecal Incontinence
• Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures	* MACE Split appendix procedure: division of appendix into two segments, so making Mitrofanoff procedure by the distal appendicular segment and Malone procedure by proximal appendicular segment. * MACE Colonic flap Neoappendecosotomy procedure: creating the colonic flap from the ascending colon, tubularization done. The tip of the neo-appendix was spatulated and sutured with the triangular skin flap of umbilicus, then the silicon catheter in place passing through the neo appendix into the colon * Mitrofanoff procedure: The appendix was mobilized with its mesentery. The tip of the appendix was incised and a 10-12Fr feeding tube was inserted to confirm patency. Then Opening of the urinary bladder was done. The distal end of the appendix was then inserted into the bladder in a submucosal tunnel. The distal opening of the appendix was sutured to the inner bladder wall and mucosa using absorbable sutures.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-07-22
• Completion: 2025-09-22
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: Egypt