Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
VAAFT-OTSC
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 29, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFebruary 6, 2024
January 1, 2024
9.5 years
January 29, 2024
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fistula healing
No leakage at all
January 2024
Secondary Outcomes (2)
Recurrence
January 2024
perianal abscess/fistula
January 2024
Study Arms (1)
Treatment Arm
VAAFT followed by OTSC clip inserted to close the inner opening of the anal fistula
Interventions
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
Eligibility Criteria
Males and females with trans-sphincteric perianal fistulas
You may not qualify if:
- Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Hospital,Dept of Surgery
Cebeci, Ankara, 06500, Turkey (Türkiye)
Related 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.
PMID: 24509459BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 6, 2024
Study Start
September 1, 2014
Primary Completion
February 20, 2024
Study Completion
April 1, 2024
Last Updated
February 6, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- September 2024
- Access Criteria
- Primary and secondary outcomes
Present it in the ESCP Meeting