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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06243302
Acronym
VAAFT-OTSC
Enrollment
60
Registered
2024-02-06
Start date
2014-09-30
Completion date
2024-04-01
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Keywords

VAAFT, OTSC, diathermy Ablation of Fistula Tract

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.

Interventions

PROCEDUREOTSC 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

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fistula healingJanuary 2024No leakage at all

Secondary

MeasureTime frameDescription
perianal abscess/fistulaJanuary 2024re-occuring abscess or fistula
RecurrenceJanuary 2024No re-occuring symptoms

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026