Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.
OBJECTIVE
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].


CONCLUSIONS
AFP is not more effective than seton removal alone to achieve FAP-CD closure.
Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon - APHP, Clichy, France agnes.senejoux@gmail.com.
A
A
Senéjoux
Hôpital Pontchaillou, Université Rennes 1, Rennes, France.
L
L
Siproudhis
Hôpital Bichat, Université Diderot Paris 7, Paris, France.
L
L
Abramowitz
Hôpital Saint-Louis, Université Diderot Paris 7, Paris, France.
N
N
Munoz-Bongrand
Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Diderot Paris 7, Paris, France.
K
K
Desseaux
Hôpital Pontchaillou, Université Rennes 1, Rennes, France.
G
G
Bouguen
Institut des Maladies de l'Appareil Digestif, CHU Nantes, Nantes, France.
A
A
Bourreille
Clinique Universitaire Saint Luc, Bruxelles, Belgique.
O
O
Dewit
Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon - APHP, Clichy, France.
C
C
Stefanescu
Hôpital Claude Huriez, Université Lille 2, Lille, France.
G
G
Vernier
CHU Sart Tilman, Université de Liège, Liège, Belgique.
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E
Louis
Hôpital Nord, Centre d'investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France.
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JC
Grimaud
CHRU de Tours, Tours, France.
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B
Godart
Hôpital Charles Nicolle, Université de Rouen UR, Rouen, Franc.
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G
Savoye
Hôpital de l'Archet, Université Nice Sophia-Antipolis, Nice, France.
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X
Hebuterne
GH Diaconesses-Croix Saint-Simon, Paris, France.
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P
Bauer
Hôpital Jean Minjoz, Université de Franche-Comté, Besançon, France.
M
M
Nachury
Hôpital Sud, Université Bordeaux Segalen, Bordeaux, France.
D
D
Laharie
Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Diderot Paris 7, Paris, France.
S
S
Chevret
Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon - APHP, Clichy, France.
Y
Y
Bouhnik
D020341:Absorbable Implants; D000328:Adult; D001705:Bioprosthesis; D003424:Crohn Disease / Q000150:complications*; D013505:Digestive System Surgical Procedures / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D010502:Perineum; D019919:Prosthesis Implantation / Q000379:methods*; D012003:Rectal Fistula / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
Crohn’s disease; anal fistula; fistula plug