Laser Assisted Treatment of Fistula In Ano
LATFIA
LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
1 other identifier
interventional
176
1 country
5
Brief Summary
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJune 15, 2022
March 1, 2022
3.5 years
April 21, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary fistula closure after index laser or flap treatment
Success rate (number of patients) of laser/flap treatment defined as full healing (fistula closure) after the index procedure
6 months
Secondary Outcomes (8)
Secondary Fistula closure
6 months
Postoperative Pain
6 months
Postoperative fecal incontinence
6 months
Postoperative wound complications
6 months
Postoperative Quality of Life
6 months
- +3 more secondary outcomes
Study Arms (2)
Laser assisted fistula closure
ACTIVE COMPARATORGroup to be actively treated with laser assisted fistula surgery
Rectal advancement flap
ACTIVE COMPARATORGroup to be actively treated with a rectal advancement flap.
Interventions
using a radial laserprobe to treat transsphincteric fistula
current golden standard in transsphincteric fistula surgery
Eligibility Criteria
You may qualify if:
- Patients with fistula involving more than one-third of the external anal sphincter
- Age ≥ 18
- Able to complete an informed written consent, understand its implications and contents, and participate in follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Universitair Ziekenhuis Brusselcollaborator
- University Hospital, Ghentcollaborator
- AZ St.-Dimpna Geelcollaborator
- Jessa Hospitalcollaborator
Study Sites (5)
Antwerp University Hospital
Edegem, Antwerpen, 2610, Belgium
Az St Dimpna Geel
Geel, Antwerpen, 2440, Belgium
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, 3500, Belgium
Gent University Hospital
Ghent, Oost- Vlaanderen, 9000, Belgium
Brussels University Hospital
Brussels, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Niels Komen, M.D. Phd
University Hospital, Antwerp
- PRINCIPAL INVESTIGATOR
Sander Van Hoof, M.D.
University Hospital, Antwerp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2022
First Posted
May 25, 2022
Study Start
March 1, 2022
Primary Completion
September 1, 2025
Study Completion
March 1, 2026
Last Updated
June 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share