Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano

Background: The aim of this randomized study was to compare the results of anal fistula plug and endorectal advancement flap in the treatment of high fistula in ano of cryptoglandular origin. Methods: Consecutive patients with high trams-sphincteric fistula in ano of cryptoglandular aetiology were randomized to treatment with either an anal fistula plug or endorectal advancement flap. Patients agreed to participate in a follow-up programme, which included scheduled visits at 2, 4, 8,12 and 24 weeks and at 1 year after surgery. The primary endpoint was effectiveness in fistula healing. Recurrence was defined as the presence of an abscess arising in the same area, or obvious evidence of fistulation. Results: A large number of recurrences in the fistula plug group led to premature closure of the trial. After 1 year, fistula recurrence was noted in 12 of 15 patients treated with an anal fistula plug compared with two of 16 treated with an endorectal advancement flap (relative risk 6.40 (95 per cent confidence interval 1.70 to 23.97); P < 0.001). Conclusion: Contrary to other published studies, an anal fistula plug was associated with a low rate of fistula healing, particularly in patients with a history of fistula surgery.