Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinnence Case Series Study (USGMS)

November 16, 2025 updated by: Ahmed Abdelrazak Mohamed Ahmed, Assiut University

Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence

Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery to treat patient with bowel incontinence by using unstimulated gluteus maximus muslce in creating neosphincter by dicussating lower third of muscle with neovascular bundle and suturing on contralateral side ischial tuberosity

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gamal Abdelhamid Professor dr gamal, Professor doctor
  • Phone Number: 01005597112 01006369722
  • Email: Eed@aun.edu.eg

Study Contact Backup

Study Locations

  • Egypt
    • University
      • Asyut, University, Egypt, 172000
        • Recruiting
        • Assiut hospital university
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmed Abdelrazak Mohamed, Resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients with severe fecal incontinence refractory to medical treatment
  • loss of native anal sphincter confirmed by MRI
  • patients deemed suitable for unstimulated gluteus maximus sphincteroplasty

Exclusion Criteria:

  • amyotrophic lateral sclerosis
  • severe scarring of bilateral gluteus maximus
  • pelvic fracture with injury of internal illiac vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Age not below 9 years
Surgery target people not below the age of 9 yearsLower gluteal crease incision and lower third fibers taken with neovascular bundle and suturing on contralateral ischial tuberosity to make external sphincter and make neosphincter
Procedure: Unstimulated gluteus maximus sphincteroplasty
Surgery done under general anethesia prone jacknige postion .. incsion made along lower gluteal crease to take lower third fibers including neurovascular bundle and dicussating subcutaneusly around anus and suturing on contralateral ischial tuberosity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of fecal incontinence
Time Frame: 6 months
Improvement of fecal incontince assessed by cleveland clinic florida fecal incontinnence score <7
6 months
Improvement of fecal incontinence
Time Frame: 6 months
Improvement of fecal incontinence assessed by cleveland clinic florida fecal incontinence score at final follow uo <7
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mahmoud Refaat Shehata, Assistant professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Dexter T, WalshawJ ,Winny H,LeoA

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anal sphincteroplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Treat patients with fecal incontinence

IPD Sharing Time Frame

Start date 2025 End date 2028

IPD Sharing Access Criteria

Everyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Informed Consent Form
    Information identifier: AssitU
    Information comments: For treatment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bowel Incontinence

Clinical Trials on Unstimulated gluteus maximus sphincteroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe