A Senéjoux1, L Siproudhis2, L Abramowitz3, N Munoz-Bongrand4, K Desseaux5, G Bouguen2, A Bourreille6, O Dewit7, C Stefanescu8, G Vernier9, E Louis10, J C Grimaud11, B Godart12, G Savoye13, X Hebuterne14, P Bauer15, M Nachury16, D Laharie17, S Chevret5, Y Bouhnik8. 1. Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon - APHP, Clichy, France agnes.senejoux@gmail.com. 2. Hôpital Pontchaillou, Université Rennes 1, Rennes, France. 3. Hôpital Bichat, Université Diderot Paris 7, Paris, France. 4. Hôpital Saint-Louis, Université Diderot Paris 7, Paris, France. 5. Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Diderot Paris 7, Paris, France. 6. Institut des Maladies de l'Appareil Digestif, CHU Nantes, Nantes, France. 7. Clinique Universitaire Saint Luc, Bruxelles, Belgique. 8. Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon - APHP, Clichy, France. 9. Hôpital Claude Huriez, Université Lille 2, Lille, France. 10. CHU Sart Tilman, Université de Liège, Liège, Belgique. 11. Hôpital Nord, Centre d'investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France. 12. CHRU de Tours, Tours, France. 13. Hôpital Charles Nicolle, Université de Rouen UR, Rouen, Franc. 14. Hôpital de l'Archet, Université Nice Sophia-Antipolis, Nice, France. 15. GH Diaconesses-Croix Saint-Simon, Paris, France. 16. Hôpital Jean Minjoz, Université de Franche-Comté, Besançon, France. 17. Hôpital Sud, Université Bordeaux Segalen, Bordeaux, France.
Abstract
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, randomised 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 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. RESULTS: In all, 54 patients were randomised 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 the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 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 the AFP group vs 8 in the controls [p = 0.07]. CONCLUSION:AFP is not more effective than seton removal alone to achieve FAP-CD closure.
RCT Entities:
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, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's diseasepatients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. RESULTS: In all, 54 patients were randomised 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 the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 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 the AFP group vs 8 in the controls [p = 0.07]. CONCLUSION: AFP is not more effective than seton removal alone to achieve FAP-CD closure.
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Authors: G Pellino; D S Keller; G M Sampietro; I Angriman; M Carvello; V Celentano; F Colombo; F Di Candido; S Laureti; G Luglio; G Poggioli; M Rottoli; S Scaringi; G Sciaudone; G Sica; L Sofo; S Leone; S Danese; A Spinelli; G Delaini; F Selvaggi Journal: Tech Coloproctol Date: 2020-03-14 Impact factor: 3.781
Authors: D Bouchard; L Abramowitz; G Bouguen; C Brochard; A Dabadie; V de Parades; M Eléouet-Kaplan; N Fathallah; J-L Faucheron; L Maggiori; Y Panis; F Pigot; P Rouméguère; A Sénéjoux; L Siproudhis; G Staumont; J-M Suduca; B Vinson-Bonnet; J-D Zeitoun Journal: Tech Coloproctol Date: 2017-09-19 Impact factor: 3.781
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Authors: A Hillary Steinhart; Remo Panaccione; Laura Targownik; Brian Bressler; Reena Khanna; John K Marshall; Waqqas Afif; Charles N Bernstein; Alain Bitton; Mark Borgaonkar; Usha Chauhan; Brendan Halloran; Jennifer Jones; Erin Kennedy; Grigorios I Leontiadis; Edward V Loftus; Jonathan Meddings; Paul Moayyedi; Sanjay Murthy; Sophie Plamondon; Greg Rosenfeld; David Schwartz; Cynthia H Seow; Chadwick Williams Journal: J Can Assoc Gastroenterol Date: 2018-09-14