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NCT Number: NCT07206719

Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures

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.

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Key information

Conditions

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

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Daboos

Cairo, 115678, Egypt

About this study

-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
  • Early as Occurrence of leak, abscess formation, intestinal obstruction, appendicular necrosis, fecal and urinary fistula formation.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    • Late as Stricture formation and requirement of secondary procedures as dribbling of urine through the urethra or soiling of stool

Secondary outcomes

  1. Patients Quality Of Life post operatively

    Time frame: 6 months

    Quality Of Life Score

    • How would you describe your child's social habits?
    • How would you describe your child's school attendance?
    • How would you describe your child's daily activity?
    • How would you describe your child's physical activity?
    • Does your child spend the night in places other than your home?
    • How would you describe how your child feels?
    • How would you describe your child's relationships with peers (like classmates)

Sponsors and collaborators

Lead sponsor

Mohammad Daboos

Other

Registry information

Official study title

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

Acronym: MitroMACE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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