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Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration (VAAFT-OTSC)

A

Ankara University

Status

Active, not recruiting

Conditions

Anal Fistula

Treatments

Procedure: OTSC Closure After VAAFT

Study type

Observational

Funder types

Other

Identifiers

NCT06243302
KRKAP-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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