Status:
UNKNOWN
Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula
Lead Sponsor:
Hospital General Universitario Reina Sofía de Murcia
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results avail...
Detailed Description
Material and method Design: Phase III, single centre, randomised, open-label, parallel group trial controlled with active comparator, with blind evaluation of results by a non-commercial third party...
Eligibility Criteria
Inclusion
- patient diagnosed with transsphincteric (medium or high) or suprasphincteric cryptoglandular anal fistula
- with no abscess at the time of surgery
- who agreed to participate and signed the informed consent form
- capable transsphincteric understanding and following study instructions
Exclusion
- diagnosed with, or with a suspected diagnosis of, Crohn's disease
- diagnosed with, or with a suspected diagnosis of, malignant anal tumour
- diagnosed with, or with a suspected diagnosis of,tuberculosis or suppurative hidradenitis
- a history of radiotherapy of the ano-perineal region
- language difficulties that prevent comprehension of the study
- refusal to participate
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05263661
Start Date
January 1 2013
End Date
January 1 2023
Last Update
March 2 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.