Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula

Abstract

There was a considerably higher recurrence rate after the anal fistula plug procedure than following advancement flap repair. Registration number: NCT01021774 (http://www.clinicaltrials.gov).

The treatment of anal fistula: secondACPGBIPosition Statement – 2018

“…The comparator group, treated with a fistula plug, achieved clinical success in only a third of patients. MRI confirmation of healing was not reported in either arm . This study represents a robustly performed assessment of transanal rectal advancement flap surgery in well‐selected patients, and is a realistic report of the technique.…”

“…A subsequent meta-analysis comparing the plug with ERAF failed to show any difference in recurrence rates or complications [181]. However, a recent robust multicentre RCT of 94 patients with a transsphincteric fistula demonstrated clinical healing at 12 months in only 38% (15 of 44 patients) treated by collagen plug, compared with 66% (27 of 41 patients) treated by ERAF [148].…”

Anal fistula plug vs rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a systematic review and meta‐analysis of studies with long‐term follow‐up

“…However, the study was based on the results after pooling of both retrospective studies and RCTs, and this can lead to bias. Recently, Bondi et al undertook a randomized prospective double-blinded multicentre trial, which produced a high level of evidence, for the comparison of AFP and RAF [3]. Their study reached a similar conclusion to Ortiz et al in that there was a higher recurrence rate after the use of the AFP than the RAF.…”

“…The inclusion criteria were as follows: (1) original research from non-RCTs or RCTs among adults; (2) the interventions of interest were AFP and RAF; (3) the [3] 2017 Norway Sweden RCT Fistula involving more than a third of the external anal sphincter AFP RAF Schwandner [17] 2013 Germany RCT(conference abstract)…”

Advancement flap procedure in Crohn and non‐Crohn perineal fistulas: a simple surgical approach

“…Rectal flap advancement is one of the sphincter‐sparing techniques. The superiority of rectal flap advancement compared to an anal plug has been shown in two randomized controlled trials . Advancement flaps were first described by Noble in 1902 and modified in 1912 and 1948 .…”