Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures

NCT07206719 | Completed DMC

• 2 other identifiers: 67-Med-0000072-8-01-0220000072-8-01-022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Surgical Outcomes

  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

  6 months

Secondary Outcomes (1)

• Patients Quality Of Life post operatively

  6 months

Study Arms (1)

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

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

Interventions

Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures PROCEDURE

* 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.

MACE and Malone

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohammad Daboos: lead

Study Sites (1)

Mohammad Daboos

Cairo, 115678, Egypt

Location

MeSH Terms

Conditions

Fecal Incontinence; Urinary Incontinence

Interventions

omega-Chloroacetophenone

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals

Study Officials

• Mohammad Daboos, prof

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.

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

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2022
• Primary Completion: July 22, 2025
• Study Completion: September 22, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

EG (1)