Gastroenterology

Gastroenterology

Volume 128, Issue 4, April 2005, Pages 856-861
Gastroenterology

Clinical-alimentary tract
Ornidazole for prophylaxis of postoperative Crohn’s disease recurrence: A randomized, double-blind, placebo-controlled trial

https://doi.org/10.1053/j.gastro.2005.01.010Get rights and content

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 (χ2, 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.

Section snippets

Patients

This randomized double-blind placebo-controlled trial was conducted at the inflammatory bowel disease centers of the University Hospital and 1 large teaching hospital. The protocol was approved by the clinical trials ethics committee of both hospitals, and all patients gave written informed consent. Only patients with ileal involvement with or without right colonic disease were included in the study.

All patients were included within 1 week of resection of all macroscopically involved bowel with

Results

Eighty patients were included in the study: 40 in the ornidazole group and 40 in the placebo arm. Two patients, both in the ornidazole arm, withdrew informed consent and did not take any drugs. They were excluded from analysis. In contrast, all patients who dropped out during the study were included in the intention-to-treat analysis.

The baseline characteristics of the 2 groups are summarized in Table 1. There was a significantly longer duration of disease in the ornidazole group than in the

Discussion

We found ornidazole to be an effective prophylactic therapy after surgery for Crohn’s disease. This nitroimidazole antibiotic prevented both bowel lesions as visualized at ileocolonoscopy and, most importantly, clinical recurrence at 1 year after surgery in this cohort of patients. The proportion of patients with clinical relapse at 1 year decreased from 37.5% in the placebo group to 7.9% in the ornidazole group. The only other clinical parameter predicting clinical recurrence was the

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Ornidazole and a grant for the study nurse were provided by Roche Belgium.

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