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NCT Number: NCT07239076

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

Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence

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Key information

Conditions

Bowel Incontinence Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

9 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut hospital university

Asyut, University, 172000, Egypt

Location status: Recruiting

Location contact

Ahmed Abdelrazak Mohamed, Resident

PRINCIPAL_INVESTIGATOR

Ahmed Sadek Mohamed, Specialist

CONTACT

[email protected]

01004542455

Mahmoud Refaat Shehata, Assistant professor

CONTACT

[email protected]

01060559662

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Improvement of fecal incontinence

    Time frame: 6 months

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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gamal Abdelhamid Professor dr gamal, Professor doctor

CONTACT

[email protected]

01006369722 ext. 01005597112

Mahmoud Refaat Shehata, Assistant professor

CONTACT

[email protected]

01060559662

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence

Acronym: USGMS

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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