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. 2019 Aug 6;2019(8):CD010233. doi: 10.1002/14651858.CD010233.pub3

Scapa 2015.

Methods Study design: RCT; abstract
Setting: Tel Aviv, Israel; study period not reported
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 = ?)
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
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
Notes Funding source: not reported
Conflict of interest: not reported
Power calculation: not reported
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