PISA Study
Research type
Research Study
Full title
Multimodal treatment of perianal fistulas in patients with Crohn's disease: seton vs anti-TNF vs advancement plasty
IRAS ID
224869
Contact name
Janindra Warusavitarne
Contact email
Sponsor organisation
Academic Medical Centre, Amsterdam
Clinicaltrials.gov Identifier
NTR 4137, Dutch Clinical Trials Registry
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A randomised controlled trial comparing seton drainage, medical treatment with anti-TNF agents and advancement flap repair of perianal fistula in Crohn's disease.
The most effective way to treat anal fistulas (tunnels of infection between the anus and the skin of the buttock) in Crohn's disease (an incurable inflammatory condition of the bowel) is unknown. Options include surgery or medical treatment to close the fistulas, or drainage with a seton (a surgical thread placed through the fistula to prevent temporary closure followed by abscess formation) to control it. Medical treatment with anti-TNF agents is expensive and half of patients will continue to have symptoms of open fistulas. Surgical repair with advancement flap closure has a similar success rate. Whilst a seton will not allow a fistula to close, it will prevent abscess formation and reduce symptoms in many patients. This study will assess the impact of these three options in a randomised trial, examining the benefit to patients' quality of life, their ability to work and the likelihood of sustained closure of the fistulas. We hope to determine which treatment option produces the best outcome for patients over the 18 months of the study.
Adult patients with new or newly symptomatic fistulas will be invited to take part. The study is international with hospitals in the Netherlands, Ireland, Italy, Belgium and the UK. The treatment options are all part of normal clinical care. Patients will be randomly allocated to one option and will undergo normal treatment with the addition of study questionnaires which will assess the patient's quality of life and any benefit gained from the treatment during the course of the study.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0467
Date of REC Opinion
20 Jul 2018
REC opinion
Further Information Favourable Opinion