Unstimulated gluteus maximus sphincteroplasty to treat bowel incontinence
Official title: Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence
Run by Assiut University · NCT07239076 · Data updated 2026-11-12
This procedure tests whether using the patient's unstimulated gluteus maximus muscle to create a new anal sphincter can help people with severe fecal incontinence that hasn't improved with other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Years to 70 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, University) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07239076 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe fecal incontinence that is refractory to medical treatment and with loss of the native anal sphincter on MRI who are considered suitable surgical candidates.
✕Probably not a fit
Patients with amyotrophic lateral sclerosis, severe scarring of both gluteus maximus muscles, pelvic fractures with damage to internal iliac vessels, or those who are not surgical candidates are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional case series uses a surgical technique that transposes the lower third of the gluteus maximus muscle, preserving its neovascular bundle, and sutures it to the contralateral ischial tuberosity to form a neosphincter without electrical stimulation. Eligible patients have severe fecal incontinence refractory to medical therapy and loss of the native anal sphincter on MRI; key exclusions include amyotrophic lateral sclerosis, severe bilateral gluteus maximus scarring, or pelvic fracture with injury to internal iliac vessels. The procedure is performed at a single center (Assiut University Hospital) and patients are followed postoperatively for continence outcomes and surgical complications. Results will be reported as a case series describing functional outcomes and safety.
Why it matters
Potential benefit: If successful, the procedure could improve continence and quality of life for patients who have not responded to other treatments.
How similar studies have gone: Related gluteus maximus sphincteroplasty techniques have been used previously with variable success in case series, but the unstimulated variant is less widely studied and not broadly adopted.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Assiut hospital university
Asyut, University, Egypt Recruiting
Study contacts
- Principal investigator: Mahmoud Refaat Shehata, Assistant professor — Assiut University
- Study coordinator: Gamal Abdelhamid Professor dr gamal, Professor doctor
- Email: Eed@aun.edu.eg
- Phone: 01006369722
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.