LATFIA Trial: FiLaC™ vs Rectal Advancement Flap in Anal Fistula
Research type
Research Study
Full title
LATFIA-trial: Laser Assisted Treatment of Fistula In Ano. Randomized Controlled Trial comparing FiLaCTM to Rectal Advancement Flap
IRAS ID
364830
Contact name
Niels Komen
Contact email
Sponsor organisation
Antwerp University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Anal fistulas are small tunnels that can form between the inside of the anus and the surrounding skin, often after an abscess or infection. They can cause persistent pain, discharge, and discomfort, and usually require surgery to heal. Treating fistulas is challenging because the tract often passes through the muscles that control continence.
The LATFIA trial (Laser Assisted Treatment of Fistula in Ano) aims to determine which of two established sphincter-preserving surgical techniques offers the best balance between healing and maintaining continence in adults with high transsphincteric anal fistulas.
The study compares:
- FiLaC™ (Fistula-tract Laser Closure) – a minimally invasive technique that seals the fistula from the inside using a laser fibre.
- Rectal Advancement Flap (RAF) – a more traditional operation using a small flap of rectal tissue to close the internal opening of the fistula.Both procedures are already used in NHS and international practice, but there is currently limited scientific evidence directly comparing their effectiveness.
Eligible participants are adults diagnosed with a high transsphincteric anal fistula who have undergone initial drainage with a “seton” and confirmation of the fistula on MRI. Participants will be randomly allocated (like flipping a coin) to receive either FiLaC™ or RAF. They will attend follow-up appointments and complete short questionnaires about healing, continence, pain, and quality of life over six months.
The trial will take place in NHS hospitals, including St Mark’s Hospital in London, in multiple centres in Belgium, France and Italy.
The study is sponsored by Antwerp University Hospital (UZA, Belgium) and aims to provide robust evidence to improve future surgical care and treatment choices for patients with anal fistulas.REC name
London - Stanmore Research Ethics Committee
REC reference
26/LO/0116
Date of REC Opinion
6 May 2026
REC opinion
Further Information Favourable Opinion