Status:
WITHDRAWN
Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound
Lead Sponsor:
Consorci Sanitari de l'Alt Penedès i Garraf
Conditions:
Perianal Fistula
Transsphincteric Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
Detailed Description
This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fis...
Eligibility Criteria
Inclusion
- Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
- Ability to understand the study, to sign the consent and to complete the follow-up.
Exclusion
- Under 18 years of age.
- Complex/recurrent fistula.
- Patients in which by clinical criteria is decided not to perform a fistulotomy.
- Anorectal malignancy.
- Crohn's desease.
- ASA IV or other contraindication for surgery.
- Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04722965
Start Date
April 1 2021
End Date
July 1 2023
Last Update
March 19 2024
Active Locations (1)
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1
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, Spain, 08810