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. 2016 May 6;2016(5):CD008914. doi: 10.1002/14651858.CD008914.pub3

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Follow‐up: adequate, withdrawn: n = 0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
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
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)
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
Notes All participants underwent PD, no participants were withdrawn, and no participants dropped out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