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

NCT07239076 | Recruiting DMC

• 1 other identifier: Anal sphincteroplasty
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence

Conditions

Bowel Incontinence

Outcome Measures

Primary Outcomes (2)

• Improvement of fecal incontinence

  Improvement of fecal incontince assessed by cleveland clinic florida fecal incontinnence score \<7

  6 months

• Improvement of fecal incontinence

  Improvement of fecal incontinence assessed by cleveland clinic florida fecal incontinence score at final follow uo \<7

  6 months

Study Arms (1)

Age not below 9 years

EXPERIMENTAL

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

Interventions

Unstimulated gluteus maximus sphincteroplasty PROCEDURE

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

Age not below 9 years

Eligibility Criteria

• Age: 9 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut hospital university

Asyut, University, 172000, Egypt

RECRUITING

Related Publications (1)

• Dexter T, WalshawJ ,Winny H,LeoA

  RESULT

Related Links

• Treatment of bowel incontinence
• Treatment of fecal incontinence

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mahmoud Refaat Shehata, Assistant professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamal Abdelhamid Professor dr gamal, Professor doctor

CONTACT

01006369722; Eed@aun.edu.eg

Mahmoud Refaat Shehata, Assistant professor

CONTACT

01060559662; Drmahmodrefaat@eun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unstimulatedgulteus maximus sphincteroplasty for treatment of bowel incontinence

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: July 1, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start date 2025 End date 2028
• Access Criteria: Everyone

Locations

EG (1)