Status:
RECRUITING
Laser Assisted Treatment of Fistula In Ano
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Conditions:
Fistula in Ano
Rectal Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
Detailed Description
A prevalent and complex fistula type is the high transsphincteric (TS) fistula. It typically runs through the upper two-thirds of the external anal sphincter (EAS) and is, due to the high risk of feca...
Eligibility Criteria
Inclusion
- Patients with fistula involving more than one-third of the external anal sphincter
- Single, continuous fistula tract at time of inclusion
- Loose seton present in fistula tract for 2 months or more at time of inclusion
- Age ≥ 18
- Able to complete an informed written consent, understand its implications and contents, and participate in follow-up
Exclusion
- Fistula tract \< 1 cm
- Complex fistula tract system (branching of fistula tract inside the sphincter complex)
- Pregnancy
- HIV-positive
- Crohn´s disease, Ulcerative colitis
- Fistula due to malignancy
- Tuberculosis
- Hidradenitis Suppurativa
- No internal opening
- Unable to undergo or contraindications to MRI
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05390151
Start Date
March 1 2022
End Date
March 1 2026
Last Update
June 15 2022
Active Locations (5)
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1
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2610
2
Az St Dimpna Geel
Geel, Antwerpen, Belgium, 2440
3
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, Belgium, 3500
4
Gent University Hospital
Ghent, Oost- Vlaanderen, Belgium, 9000