Unstimulated gluteus maximus sphincteroplasty to treat bowel incontinence
Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 9 Years to 70 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, University) |
| Trial ID | NCT07239076 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Asyut, University
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.