| 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 |
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| 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) |
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| Outcomes | Primary outcome: the proportion of patients with endoscopic and clinical recurrence at 2 years Secondary outcomes: quality of life (IBD‐Q), adverse events |
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| 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 |