Laser treatment for anal fistulas
Official title: LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
Run by University Hospital, Antwerp · NCT05390151 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether a new laser treatment for anal fistulas works better than the traditional surgery method for people who have been dealing with this condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 176 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 5 sites (Edegem, Antwerpen and 4 other locations) |
| Trial ID | NCT05390151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a single, continuous high transsphincteric fistula that has been managed with a loose seton for at least two months.
✕Probably not a fit
Patients with complex fistula systems, inflammatory bowel disease, or other specified exclusions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness of laser-assisted closure of high transsphincteric fistulas to the traditional rectal advancement flap method. Participants will have a single, continuous fistula that has been treated with a loose seton for at least two months and will undergo MRI mapping. The laser technique uses a radial-emitting fiber to destroy the fistula tissue without damaging the surrounding sphincter muscles, while the rectal advancement flap involves excising the fistula and using surrounding tissue to close the defect. The goal is to determine which method provides better outcomes for patients with this complex condition.
Why it matters
Potential benefit: If successful, this treatment could offer a less invasive option for patients with high transsphincteric fistulas, potentially reducing recovery time and complications.
How similar studies have gone: While laser-assisted techniques are gaining interest, this specific comparison with the rectal advancement flap is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Antwerp University Hospital
Edegem, Antwerpen, Belgium Recruiting -
Az St Dimpna Geel
Geel, Antwerpen, Belgium Recruiting -
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, Belgium Recruiting -
Gent University Hospital
Gent, Oost- Vlaanderen, Belgium Not yet recruiting -
Brussels University Hospital
Brussels, Belgium Not yet recruiting
Study contacts
- Principal investigator: Sander Van Hoof, M.D. — University Hospital, Antwerp
- Study coordinator: Sander Van Hoof, M.D.
- Email: sander.vanhoof@uza.be
- Phone: +3238212434
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perianal disease and its impact on sexual life
This project will see how chronic perianal conditions (like fistulas, perianal Crohn’s, or pilonidal disease) affect sexual function and self‑esteem in adults who can complete Greek questionnaires.
-
ECMT-100 ECM hydrogel to close high transsphincteric anorectal fistulas
This trial tests a mucoadhesive ECM hydrogel (ECMT-100) placed into the fistula tract to try to close high transsphincteric anorectal fistulas in adults who have had a seton in place.
-
BioHealx device long-term follow-up for closing anal fistulas
This study will see if the BioHealx implant can close and keep closed anal fistulas in adults with a single continuous fistula who have had a draining seton.
-
Comparing collagen paste and mucosal advancement flap for treating fistula-in-ano
This study tests whether using collagen paste or surgery works better for healing high anal fistulas while keeping the anal sphincter functioning well.
-
Evaluating non-cutting seton placement for fistula-in-ano in children
This study tests how long a special thread, called a seton, should be used to treat fistula-in-ano in children to see which duration helps them feel better.
-
Using stem cells from umbilical cords to treat perianal fistulas in Crohn's disease patients
This study is testing if injections of stem cells from umbilical cords can safely help people with Crohn's disease heal complex perianal fistulas.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.