Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures (MitroMACE)

Mohammad Daboos

Status: Completed

Conditions: Fecal Incontinence; Urinary Incontinence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07206719

0000072-8-01-022 (Other Identifier)

67-Med-0000072-8-01-022

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MACE and Malone

Experimental group

Description:

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

Treatment:

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