| Methods | Randomised, multi‐centre double‐blind, double‐dummy, controlled trial | |
| Participants | CD patients before postoperative hospital discharge after ileocolic resection with a primary anastomosis for disease confined to the ileum and adjacent colon (N = 131) Patients were excluded if there was evidence of disease proximal or distal to the site of resection |
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| Interventions | 6‐mercaptopurine 50 mg/day for 24 months (n = 47) mesalamine 3 g/day for 24 months (n = 44) placebo for 24 months (n = 40) |
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| Outcomes | Primary outcomes: clinical relapse (score of > 2 on the clinical recurrence grading scale) at 6, 12 and 24 months, radiographic relapse (a score of > 2 on the radiological recurrence grading scale) or endoscopic recurrence (score of > 2 on the Rutgeerts endoscopic scoring system) at 12 and 24 months Secondary outcome: adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomisation in blocks of 6 |
| Allocation concealment (selection bias) | Low risk | Centralized pharmacy randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind Identical matching placebo |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Full data reported |
| Selective reporting (reporting bias) | Low risk | Appropriate data reported |
| Other bias | Low risk | None apparent |