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

Anal Fistula Clinical Trial

— VAAFT-OTSC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06243302
• Other study ID #: KRKAP-002
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• OTSC Closure After VAAFT
Under general anesthesia,the fistulas will be drained at least for 8 weeks. Then a video camera will be inserted through the external opening to fulgurate the fistula tract under direct vision. Finally the internal fistula opening will be closed water tight by a circular clip. The patients will be followed up for complications as well as short and long term recurrences

Locations

Country	Name	City	State
Turkey	Ankara University Hospital,Dept of Surgery	Cebeci	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula healing	No leakage at all	January 2024
Secondary	Recurrence	No re-occuring symptoms	January 2024
Secondary	perianal abscess/fistula	re-occuring abscess or fistula	January 2024