Skip to main content
Clinical Trials/NCT07206719
NCT07206719CompletedNot Applicable

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

Mohammad Daboos1 site in 1 country30 target enrollmentStarted: January 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Surgical Outcomes

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

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.

Eligibility Criteria

Ages
5 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

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

Intervention: Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures (Procedure)

Outcomes

Primary Outcomes

Surgical Outcomes

Time Frame: 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

Secondary Outcomes

  • Patients Quality Of Life post operatively(6 months)

Investigators

Sponsor
Mohammad Daboos
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mohammad Daboos

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

Al-Azhar University

Study Sites (1)

Loading locations...

Similar Trials