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

NCT ID: NCT07239076

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-07-01

Brief Summary

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Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence

Detailed Description

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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

Conditions

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Bowel Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Unstimulated gluteus maximus sphincteroplasty

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelrazak Mohamed Ahmed

Unstimulatedgulteus maximus sphincteroplasty for treatment of bowel incontinence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Refaat Shehata, Assistant professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut hospital university

Asyut, University, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Gamal Abdelhamid Professor dr gamal, Professor doctor

Role: CONTACT

01006369722 ext. 01005597112

Mahmoud Refaat Shehata, Assistant professor

Role: CONTACT

01060559662

Facility Contacts

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Mahmoud Refaat Shehata, Assistant professor

Role: primary

01060559662

Ahmed Sadek Mohamed, Specialist

Role: backup

01004542455

References

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Dexter T, WalshawJ ,Winny H,LeoA

Reference Type RESULT

Study Documents

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Document Type: Informed Consent Form

For treatment

View Document

Related Links

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Other Identifiers

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Anal sphincteroplasty

Identifier Type: -

Identifier Source: org_study_id

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