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