Scapa 2015.
Methods |
Study design: RCT; abstract Setting: Tel Aviv, Israel; study period not reported |
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Participants |
Inclusion: All CD patients undergoing a first ileocecectomy for inflammatory complications were prospectively recruited to the Post OPerative Adalimumab Recurrence Trial (POPART). Exclusion: Not reported Age (IG1 / IG2) median (SD): overall not reported; 30.5 ± 2.3 years versus 34.4 ± 2.5 years Sex (M:F): not reported Type of surgery: not reported Previous surgery (IG1+IG2): not reported Start of intervention after surgery: < 45 days Medication use (IG1+ IG2): Not reported Smoker (IG1 / IG2): 4 (1/3) Number randomised (N = 19) Number analysed (N = 19): (8) versus (11) Post‐randomisation exclusion (n = ?) |
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Interventions |
Group 1: Thiopurine (6‐mercaptopurine 1.5 mg/kg/day) Group 2: Adalimumab 160 mg/ 80 mg and then 40 mg every other week All participants: All patients underwent ileocolonoscopy at 6 and 12 months to asses for endoscopic recurrence as defined by the Rutgeert's score |
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Outcomes |
Duration of study: 12 months 1. Endoscopic recurrence defined as a Rutgeert's score of i0‐i1, while advanced lesions were defined as i2 to i4 |
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Notes |
Funding source: not reported Conflict of interest: not reported Power calculation: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to make judgment |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to make judgment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make judgment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to make judgment |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Nineteen patients have reached the 24‐week time point" Comment: Abstract does not report how many were randomised, the number of withdrawals, no information regarding any adverse event. Authors informed us via correspondence (12/10/2018) that the full trial will be published by end of 2018, but refused to share trial data |
Selective reporting (reporting bias) | High risk | Trial registration available (NCT01629628), however clinical relapse and adverse events were not reported in the Abstract. Authors informed us via correspondence (12/10/2018) that the full trial will be published by end of 2018, but refused to share trial data |
Other bias | Unclear risk | Insufficient information to make judgment |
RCT: randomised controlled trial; CD: Crohn's disease; CDAI: Crohn's disease activity index; IG: intervention group; SD: standard deviation; M: male; F: Female; TNF: tumour necrosis factor; AZA: azathioprine; ITT; intention‐to‐treat; mg: milligram; kg: kilogram; g: gram; WBC: white blood cell count; μu/ml: micro units per millilitre; INF: infliximab; 5‐ASA: 5‐aminosalicylic acid; 6‐MP: 6‐mercaptopurine; L: litre; ADA: adalimumab; NSAID; non‐steroidal anti‐inflammatory drugs; IBDQ: inflammatory bowel disease questionnaire; cm: centimetre