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Updated: May 11, 2026

Murine Ileocolic Bowel Resection with Primary Anastomosis
Published on: October 29, 2014
Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind,
Paul Rutgeerts1, Gert Van Assche, Séverine Vermeire
1Department of Gastroenterology, University Hospital Gasthuisberg, 3000 Leuven, Belgium. Paul.Rutgeerts@uz.kuleuven.ac.be
Background & Aims:
Crohn's disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified. We investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn's disease after curative ileocolonic resection in a placebo-controlled double-blind clinical trial.
Methods:
Eighty patients were randomized to ornidazole 1 g/day or placebo started within 1 week of resection and continued for 1 year. The primary end point was the proportion of patients with clinical recurrence at 1 year. Secondary end points were endoscopic recurrence at 3 months and 12 months after resection.
Results:
Two patients in the ornidazole group withdrew consent and were not dosed. Ornidazole significantly reduced the clinical recurrence rate at 1 year from 15 of 40 (37.5%) patients in the placebo group to 3 of 38 (7.9%) patients in the ornidazole group (Fisher exact test, 8.03; P = .0046; odds ratio, 0.14; 95% confidence interval, 0.037-0.546). Ornidazole reduced endoscopic recurrence at 12 months from 26 of 33 (79%) in the placebo group to 15 of 28 (53.6%) in the ornidazole group (chi2 , 4.37; P = .037; odds ratio, 0.31; 95% confidence interval, 0.10-0.94). Endoscopic recurrence at 3 and 12 months predicted clinical recurrence. Significantly more patients in the ornidazole group dropped out from the study because of side effects (P = .041).
Conclusions:
Ornidazole 1 g/day is effective for the prevention of recurrence of Crohn's disease after ileocolonic resection.
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