Laser treatment for anal fistulas
LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 5 sites (Edegem, Antwerpen and 4 other locations) |
| Trial ID | NCT05390151 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with complex fistula systems, inflammatory bowel disease, or other specified exclusions will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edegem, Antwerpen and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.