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

January 29, 2024 updated by: I Ethem Gecim, Ankara University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Cebeci, Ankara, Turkey, 06500
        • Ankara University Hospital,Dept of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Males and females with trans-sphincteric perianal fistulas

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Arm
VAAFT followed by OTSC clip inserted to close the inner opening of the anal fistula
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula healing
Time Frame: January 2024
No leakage at all
January 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: January 2024
No re-occuring symptoms
January 2024
perianal abscess/fistula
Time Frame: January 2024
re-occuring abscess or fistula
January 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

February 20, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRKAP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Present it in the ESCP Meeting

IPD Sharing Time Frame

September 2024

IPD Sharing Access Criteria

Primary and secondary outcomes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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