Published February 2016 | Version v1
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Fistula plug in fistulising ano-perineal Crohn's disease: a randomized controlled trial

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Background and aims: Anal fistula plug (AFP) is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease (FAP-CD). Methods: In a multicentre, open-label, randomized controlled trial we compared seton removal alone (control group) with AFP insertion (AFP group) in 106 Crohn's disease patients with non or mildly active disease having at least one ano-perineal fistula tract drained for more than one month. Patients with abscess (collection ≥ 3 mm on MRI) or recto-vaginal fistulas were excluded. Randomization was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at week 12.Results54 patients were randomized to AFP group (control group 52). Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at week 12 was achieved in 31.5% patients in AFP group and in 23.1 % in control group (relative risk stratified on AGA classification, RR: 1.31; 95%CI: 0.59-4.02; p=0.19). No interaction in treatment effect with complexity stratum was found. 33.3% patients with complex fistula and 30.8% patients with simple fistula closed the tracts after AFP, as compared to 15.4% and 25.6% in controls respectively (RR of success=2.17 in complex fistula vs. RR=1.20 in simple fistula; p= 0.45). Concerning safety, at week 12, 17 patients developed at least one adverse event in AFP group vs. 8 in controls (p=0.07). Conclusion: AFP is not more effective than seton removal alone to achieve FAP-CD closure

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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01201951
URN
urn:oai:HAL:hal-01201951v1

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UNICA