Study Stopped
Feasibility problems to patients recruitment.
Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound
Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2021
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
January 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMarch 19, 2024
March 1, 2024
1.8 years
January 21, 2021
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing time
Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.
6 weeks
Secondary Outcomes (10)
Postoperative pain
6 weeks
Return to daily activities
6 weeks
Operating time
60 minutes
Hospitalization time
2 days
Bleeding of the postoperative wound
6 weeks
- +5 more secondary outcomes
Study Arms (2)
Fistulotomy with marsupialization
ACTIVE COMPARATOR40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.
Fistulotomy with open wound
ACTIVE COMPARATOR40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.
Interventions
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization.
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, 08810, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Gonzales, MD
CSAPG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2021
First Posted
January 25, 2021
Study Start
April 1, 2021
Primary Completion
February 1, 2023
Study Completion
July 1, 2023
Last Updated
March 19, 2024
Record last verified: 2024-03