Can Postoperative Relapse of Crohn's Disease Be Prevented?

Dumois, Richard Anthony; Herrera, Jorge L.; Johnson, David
January 2001
American Journal of Gastroenterology;Jan2001, Vol. 96 Issue 1, p249
Academic Journal
To determine if long-term treatment with high dose of mesalamine reduces the risk of clinical relapse of Crohn's disease after surgical resection, a prospective, randomized, double-blind multicenter trial was conducted. Three hundred eighteen patients who underwent surgical resection for Crohn's disease between July 1992 and April 1995 were included; 154 were randomized to receive mesalamine therapy, and 170 received placebo. Treatment with 4 g of ethyl cellulose-encapsulated mesalamine daily was started within 10 days after surgery and continued for a total of 18 months. Postoperatively, all Crohn's-related medications were discontinued, corticosteroids had to be tapered within 6 wk after surgery at the latest. The primary outcome parameter was clinical relapse as defined by one of the following: a CDAI above 250, an increase in the CDAI above 200 by a minimum of 60 points for 2 consecutive wk, need for repeat surgery, new fistula formation, or septic complications related to Crohn's disease. The secondary outcome parameter was endoscopic relapse. During the study period, Crohn's disease relapsed in 86 (27%) patients. Of the relapsing patients, 24.5% were in the mesalamine group versus 31.4% in the placebo group. This difference did not reach statistical significance. Retrospective analysis revealed a significantly reduced relapse rate with mesalamine only in the subgroup of patients with isolated small bowel Crohn's disease (n = 124; 21.8% ± 5.6% vs 39.7% ± 6.1%; p = 0.002). The probability of relapse was predominantly influenced by the duration of disease and steroid intake before surgery. The authors concluded that 18 months of high dose mesalamine did not significantly affect the postoperative course of Crohn's disease except in patients with isolated small bowel disease.


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