The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial.

BACKGROUND The anal fistula plug was developed as an alternative treatment for perianal fistulas. OBJECTIVE This study aimed to compare the anal fistula plug with the mucosal advancement flap for the treatment of high transsphincteric fistulas. DESIGN This study was a double-blinded, multicenter, randomized trial. PATIENTS Sixty patients with perianal fistulas were randomly assigned to receive an anal fistula plug or a mucosal advancement flap and were blinded for the type of treatment. MAIN OUTCOME MEASURES The outcome measures comprised the closure rate, postoperative pain, continence (colorectal functional outcome, Vaizey, and Wexner scores), and quality of life. Closure was determined by clinical examination by a surgeon blinded for the intervention. RESULTS At a follow-up of 11 months the recurrence rates were 71% (n = 22) in the anal fistula plug group and 52% (n = 15) in the mucosal advancement flap group, which was not significantly different. There were no significant differences in postoperative pain, in pre- and postoperative incontinence scores, soiling, and quality of life. CONCLUSIONS The results of the anal fistula plug and advancement flap procedures are disappointing in the multicenter setting. There were no significant differences in recurrence, functional outcome, and quality of life between the plug and the advancement flap. Because the plug is simple to apply and minimally invasive, it can be considered as an initial treatment option for high transsphincteric fistulas.