ArticlesCrohn's disease management after intestinal resection: a randomised trial
Introduction
70% of patients with Crohn's disease need intestinal resection.1, 2, 3, 4, 5 Within 1 year of surgery, subclinical endoscopic recurrence occurs at the anastomosis in 90% of patients with Crohn's disease, symptomatic clinical recurrence occurs in 30%, and 5% of patients have undergone further surgical intervention.6, 7, 8 70% of patients who have had operations need further surgery.1, 9
Smoking, perforating disease, and previous resection have been identified individually from retrospective studies as risk factors for earlier postoperative recurrence.2, 10, 11, 12 These factors have neither been assessed prospectively nor have they been used to tailor postoperative therapy.
Recurrent mucosal disease after surgery precedes clinical symptoms, and its severity predicts subsequent clinical disease.8 Early endoscopy might therefore help to guide therapeutic decision making; however, such an approach has not been assessed prospectively.13, 14
Metronidazole is of modest benefit in reduction of postoperative recurrence,15 whereas metronidazole combined with a thiopurine is moderately effective.16 Anti-tumour necrosis factor (anti-TNF) therapy is the most effective therapy for post-operative Crohn's disease,17, 18, 19 but studies for this indication have had a small sample size, and its optimal method of use postoperatively is yet to be established.
This study compared strategies to prevent disease recurrence, taking into account risk of recurrence, efficacy of different drug regimens, and assessment of the benefit of endoscopic monitoring with treatment intensification for mucosal disease recurrence, and aimed to identify the optimal strategy to prevent disease recurrence. Mucosal endoscopic normality was the target in this treat-to-target study.
Section snippets
Study design and patients
In this randomised postoperative Crohn's endoscopic recurrence (POCER) trial, consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis, were included at 17 hospitals in Australia and New Zealand. The diagnosis of Crohn's disease was based on standard clinical, imaging, and laboratory criteria.20 Patients were excluded if they had an anastomosis that was endoscopically inaccessible by standard colonoscopy;
Results
Between Oct 13, 2009, and Sept 28, 2011, 128 patients were randomly assigned to active care and 56 to standard care (figure 2). 174 patients (122 active care, 52 standard care) received at least one study drug dose and were included in the analysis. 133 patients underwent ileocaecal resection, 15 simultaneous ileocaecal and proximal small intestinal resection, 12 ileal resection, 8 subtotal colectomy, and 6 simultaneous ileocaecal with sigmoid resection. 122 patients were randomly assigned to
Discussion
Postoperative drug therapy, according to clinical risk of recurrence, with colonoscopy at 6 months and treatment step-up for recurrence, is significantly better than standard care alone for prevention of Crohn's disease recurrence (panel). The study inclusion of low and high risk patients with a variety of previous treatments was intended to reflect real-life practice, and as such we randomly assigned 184 of 212 consecutive screened patients. Furthermore, this heterogeneous group of patients
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