Fecal IncontinenceMitroMACENCT07206719
Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures
A study testing Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures in people with Fecal Incontinence and Urinary Incontinence, run by Mohammad Daboos at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Fecal Incontinence, Urinary Incontinence
- What is being tested?
- Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all patients suffering from combined fecal and urinary incontinence due to neuropathic etiology
- failure of all trials of non-surgical managements
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures for Management of Neuropathic Fecal and Urinary Incontinence in Children
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.
Read the 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
- 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
- Conditions
- Fecal Incontinence, Urinary Incontinence
- Being tested
- Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures
- Keywords
- Urinary incontinence, Fecal incontinence, Quality of life, Mitrofanoff procedure, Malone procedure
- Medical subject headings
- Fecal Incontinence, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malone Antegrade Continent Enema (MACE) and Mitrofanoff proceduresProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Outcomes
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
Measured: 6 months
Secondary outcomes (1)
Patients Quality Of Life post operatively
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2022
- Primary completion22 Jul 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MACE Split appendix procedure: MACE Colonic flap Neoappendecosotomy procedure Mitrofanoff procedure:
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Daboos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Daboos, Al-Azhar University
- Investigators
- Mohammad Daboos, prof, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206719
- Sponsor's protocol ID
- 67-Med-0000072-8-01-022
- Other IDs
- 0000072-8-01-022
- Acronym
- MitroMACE
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Concurrent MACE and Mitrofanoff Procedures for Management of Neuropathic Fecal and Urinary Incontinence in Children
- ClinicalTrials.gov ID
- NCT07206719
- Acronym / sponsor ID
- MitroMACE / 67-Med-0000072-8-01-022
- Conditions
- Fecal Incontinence, Urinary Incontinence
- Keywords
- Urinary incontinence, Fecal incontinence, Quality of life, Mitrofanoff procedure, Malone procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mohammad DaboosUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MACE Split appendix procedure: MACE Colonic flap Neoappendecosotomy procedure Mitrofanoff procedure:
| Arm | Type | Receives |
|---|---|---|
| MACE and Malone | Experimental | Procedure: Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedurespatients 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 |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- all patients suffering from combined fecal and urinary incontinence due to neuropathic etiology
- failure of all trials of non-surgical managements
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malone 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. | Procedure or surgery | MACE and Malone |
Primary outcome
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
1 secondary outcome
Patients Quality Of Life post operatively
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Daboos, prof principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malone Antegrade Continent Enema (MACE) and Mitrofanoff procedures in people with Fecal Incontinence and Urinary Incontinence, run by Mohammad Daboos at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.