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P210. Azathioprine versus azathioprine plus metronidazole for the prevention of postoperative endoscopic recurrence of Crohn's disease: A randomized, placebo-controlled trial

M. Mañosa1, E. Cabré1, I. Bernal1, M. Esteve2, E. Garcia-Planella3, E. Ricart Gómez4, M. Peñalva5, X. Cortés6, J. Boix7, M. Piñol8, M.A. Gassull1, E. Domènech9

1Hospital Universitari Germans Trias i Pujol, Dept. of Gastroenterology, Badalona, Spain; 2Hospital Universitari MútuaTerrassa, Gastroenterology, Terrassa, Spain; 3Hospital De La Santa Creu i De Sant Pau, Barcelona, Spain; 4Hospital De Sant Pau, Barcelona, Spain; 5Hospital Universitari De Bellvitge, L'Hospitalet Del Llobregat, Spain; 6Hospital Sagunto, Gastroenterology, Sagunto, Spain; 7Hospital Universitari Germans Trias i Pujol, Badalona, Spain; 8Hospital Universitari Germans Trias i Pujol, Dept. of Surgery, Badalona, Spain; 9Hospital Universitari Germans Trias i Pujol, Servicio de Aparato Digestivo, Badalona, Spain

Background: Endoscopic recurrence occurs in up to 80% of Crohn's disease (CD) patients one year after intestinal resection. Imidazolic antibiotics, thiopurines, and particularly their combination, have proven efficacy in preventing endoscopic recurrence. The aims of the study were to evaluate the efficacy of the association of metronidazole (for 3 months after surgery) to azathioprine (AZA) for the prevention of postsurgical endoscopic recurrence in CD, as compared to AZA plus placebo.

Methods: After signed informed consent, CD patients undergoing intestinal resection with ileocolic anastomosis were randomized to receive metronidazole 15–20 mg/kg/day or placebo for 3 months, in addition to AZA 2–2.5 mg/kg/day. Patients were followed clinically every 3 months. Ileocolonoscopy was performed at 6 and 12 months after surgery. Treatment failure was defined as the occurrence of endoscopic recurrence as defined by a Rutgeerts' score greater than 1 at 6 or 12 months.

Eudract study number: 2004–001795–39

Results: Fifty patients were included (25 in each treatment arm), 57% were active smokers and 48% were operated on because of penetrating CD complications. Endoscopic recurrence occurred in 21.7% and 36.4% at 6 months (P = 0.226), and in 30.4% and 50% at 12 months (P = 0.15), in the metronidazole and placebo groups, respectively. No differences were also found between treatment groups when severe endoscopic recurrence (as defined by a Rutgeerts' score greater than 2) at 6 months was evaluated (17.4% and 27.3%, respectively – P = 0.33). The rate of adverse events was also similar in both study groups (40% in placebo group vs 60% in metronnidazole group, P = 0.2).

Conclusions: The addition of metronidazole for the first three months after intestinal resection does not increase the efficacy of azathioprine alone in preventing postoperative endoscopic recurrence in CD.