Randomized clinical trial of anal fistula plugversusendorectal advancement flap for the treatment of high cryptoglandular fistulain ano

Abstract

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 trans-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.

Predictors of Outcome for Anal Fistula Surgery

“…The early experience with the anal fistula plug was very promising, but more recent studies have shown success rates from 20% to 34%, which are consistent with our results. 9,14,15,25,26,30 Two retrospective studies and 1 randomized prospective study compared anal fistula plugging with endorectal fistula in patients with transsphincteric fistulas. 25,26,30 In all 3 studies, the endorectal advancement flap had a better outcome with a success rate of 62% to 88% compared with the 20% to 34% seen with the plug.…”

Apropos use of biological mesh in trans-anal treatment for recurrent recto-urethral fistula

“…However, the literature mentions a high rate of recurrences and infective complications (sepsis, suppuration, or abscesses) following the use of such devices in anorectal conditions [3,4]. It is not unreasonable to expect some of these complications or recurrences when the plug is being used in a recto-urethral repair as well.…”

Endorectal Advancement Flap

“…The mean time to recurrence has been found to range widely from a median of 8 weeks to 9 months [ 10 -12 ]. Some studies show the majority of recurrences occurring within the fi rst year [ 13 ], or even all recurrences occurring within the fi rst 3 months [ 14 ], while other studies have shown recurrences up to 55 months after surgery [ 7 , 15 ]. Studies designed specifi cally to examine the length of follow-up needed to capture all recurrences demonstrate that the majority of recurrences occur early.…”