The Fistula In Ano Trial Comparing the Biodesign Surgisis Anal Fistula Plug vs Surgeon’s Preference for Transphincteric Fistula in Ano
Dr. Jayne presented the results of the FIAT trial (Fistula In Ano Trial), which involved 50 centers within the UK randomizing 304 patients for the fistula plug versus other surgical treatments for fistula over a 5-year period. The surgical procedures performed were fistulotomy, cutting seton, LIFT, and advancement flap.
Approximately 50% of patients had undergone previous fistula treatments. A total of 152 patients were allocated to each arm. The primary outcomes were the fecal incontinence and quality of life scores, with a low rate of incontinence and overall similar outcomes in both groups. There were no statistical significant differences on fistula healing between arms, as well as for complications, except for pain, which was significantly higher with the fistula plug. Extrusion remains a concern for this procedure, with up to 15%. Re-interventions are very common, with approximately 50% of further intervention in 12 months. More data should be collected regarding the economics and long-term follow-up of patients.