Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration

Active, not recruiting

• Conditions: Anal Fistula
• Interventions: Procedure: OTSC Closure After VAAFT

• Registration Number: NCT06243302
• Lead Sponsor: Ankara University

Brief Summary

This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.

Detailed Description

Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.

Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.

Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-02-20
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with trans-sphincteric and inter-sphincteric perianal fistulae

Exclusion Criteria

• Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Arm	OTSC Closure After VAAFT	VAAFT followed by OTSC clip inserted to close the inner opening of the anal fistula

Primary Outcome Measures

Name	Time	Method
Fistula healing	January 2024	No leakage at all

Secondary Outcome Measures

Name	Time	Method
Recurrence	January 2024	No re-occuring symptoms
perianal abscess/fistula	January 2024	re-occuring abscess or fistula

Trial Locations

Locations (1)

Ankara University Hospital,Dept of Surgery; 🇹🇷 Cebeci, Ankara, Turkey