Clinical—Alimentary TractTherapy of Metronidazole With Azathioprine to Prevent Postoperative Recurrence of Crohn's Disease: A Controlled Randomized Trial
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Patients
All consecutive patients undergoing curative ileal or ileocolonic resection with ileocolonic anastomosis for CD at 2 teaching hospitals (University Hospital Leuven and Imelda General Hospital, Bonheiden, Belgium) between August 1999 and September 2005 were invited to participate in the trial. A requirement for eligibility was the presence of ≥1 risk factor for the development of early/severe postoperative recurrence of their CD, based on the available literature: young age (<30 years); active
Patient Population
The characteristics of the study populations in the AZA and placebo group were comparable (Table 2). Eighty-one patients agreed to participate in the study and were randomized (37 female/44 male [46%/54%]; mean age 40.2 ± 12.05 years). Five patients had used AZA before their surgery (3 in the AZA group, duration 6, 12, and 18 months and 2 in the placebo group, duration 6 and 36 months). Twenty-one patients were on corticosteroids at the time of surgery and 23 had already had an earlier
Discussion
This study demonstrates that patients with an elevated risk of developing postoperative recurrence of CD have a lower likelihood of severe recurrence when they receive treatment with a 3-month induction treatment of metronidazole in combination with AZA: Significant endoscopic recurrence was observed in 14 of 32 patients (43.7%) in the AZA group and in 20 of 29 (69.0%) patients in the placebo group at 12 months postsurgery (P = .048), with absence of inflammatory lesions at month 12 in 1 of 29
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