Laser Assisted Treatment of Fistula In Ano (NCT05390151) | Clinical Trial Compass
UnknownNot Applicable
Laser Assisted Treatment of Fistula In Ano
Belgium176 participantsStarted 2022-03-01
Plain-language summary
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Primary fistula closure after index laser or flap treatment