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. 2014 Aug 1;2014(8):CD010233. doi: 10.1002/14651858.CD010233.pub2
Methods Open‐label, randomised, controlled trial
Participants Adult patients with ileal or ileocolonic CD undergoing resection (N = 51)
Exclusion criteria: more than 10 years of Crohn's disease requiring first resection for short (10 cm) fibrostenotic stricture, macroscopically active disease not resected during surgery, or the presence of a stoma
Interventions Adalimumab 160/80 mg at weeks 0 and 2, followed by 40 mg every 2 weeks for 2 years (n = 16)
Azathioprine 2.0 mg/kg/day for 2 years (n = 17)
Mesalamine 3 g/day for 2 years (n = 18)
Outcomes Primary outcome: the proportion of patients with endoscopic and clinical recurrence at 2 years
Secondary outcomes: quality of life (IBD‐Q), adverse events
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Low risk "Patient allocation was concealed and performed by an independent nurse not involved with the trial"
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label
Incomplete outcome data (attrition bias) All outcomes Low risk One patient withdrew from the adalimumab group due to atopic dermatitis
Two patients withdrew from the azathioprine group due to a severe exacerbation of Crohn's disease or an adverse event (severe abdominal pain and increase of pancreatic enzymes
Two patients withdrew from the 5‐ASA group due to severe exacerbation of Crohn's disease
Selective reporting (reporting bias) Low risk Appropriate data reported
Other bias Low risk None apparent