Wang 2014.
Methods | A prospective randomized controlled trial (registration no. ChiCTR‐TRC‐14004830)
Allocation sequence: adequate, reported computer‐generated random numbers Allocation concealment: adequate. We considered both allocation sequence generation and allocation concealment to be adequate. Blinding: no mention Follow‐up: adequate, withdrawn: n = 0 Dropouts: n = 0 Intention‐to‐treat analysis: no mention Sample size calculation: no mention Informed consent: reported Ethics committee: approval |
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Participants | Country: China Single center: Department of Hepatobiliary and Pancreatic Surgery, the First Affiliated Hospital, Harbin Medical University, 219 participants were accrued from 1 January 2010 to 1 March 2013 No. randomized: 219 Age: 24 to 77 years Gender: Male/Female: 113/106 Inclusion criteria: Underwent PD Definition of pancreatic fistula: ISGPF (2005) definition Conflicts of interest: none |
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Interventions | All participants underwent PD. 219 participants were randomly assigned to 1 of 2 groups: Group 1: External drainage (n = 110) Group 2: Internal drainage (n = 109) |
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Outcomes | The main outcome measures were: Mortality, morbidity of pancreatic fistula Delayed gastric emptying Abdominal infection Intestinal obstruction Overall complications Intraoperative blood loss Operative duration Postoperative hospital stay |
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Notes | All participants underwent PD, no participants were withdrawn, and no participants dropped out | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reported computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not clearly reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not explained |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information |
Selective reporting (reporting bias) | Low risk | Reported detailed outcomes |
Other bias | Unclear risk | No mention |