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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07206719
Acronym
MitroMACE
Enrollment
30
Registered
2025-10-03
Start date
2022-01-01
Completion date
2025-09-22
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence, Urinary Incontinence

Keywords

Urinary incontinence, Fecal incontinence, Quality of life, Mitrofanoff procedure, Malone procedure

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

Interventions

PROCEDUREMalone 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.

Sponsors

Mohammad Daboos
Lead SponsorOTHER

Study design

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.

Intervention model description

MACE Split appendix procedure: MACE Colonic flap Neoappendecosotomy procedure Mitrofanoff procedure:

Eligibility

Sex/Gender
ALL
Age
5 Years to 14 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Surgical Outcomes6 monthsComplication 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

MeasureTime frameDescription
Patients Quality Of Life post operatively6 monthsQuality Of Life Score 1. How would you describe your child's social habits? 2. How would you describe your child's school attendance? 3. How would you describe your child's daily activity? 4. How would you describe your child's physical activity? 5. Does your child spend the night in places other than your home? 6. How would you describe how your child feels? 7. How would you describe your child's relationships with peers (like classmates)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026