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. 2016 Oct 21;2016(10):CD010583. doi: 10.1002/14651858.CD010583.pub3
Methods Randomized controlled trial.
Participants Country: China.
Number randomized: 160.
Postrandomization dropout: 0 (0%).
Mean age: 59.6 years.
Females: 42 (26.3%).
Pancreatic cancer: 53 (33.1%).
Biliary cancer: 36 (22.5%).
Duodenal cancer: 28 (17.5%).
Ampullary cancer: 33 (20.6%).
Chronic pancreatitis: 5 (3.1%).
Pancreaticoduodenectomy: 160 (100%).
Distal pancreatectomy: 0 (0%).
Other pancreatic surgery: 0 (0%).
Inclusion criteria:
  1. People with planned pancreaticoduodenectomy.


Exclusion criteria:
  1. People who had undergone explorative laparotomy.

  2. People who had undergone distal pancreatectomy.

Interventions Participants (N = 160) were randomly assigned to 1 of 2 groups.
Group 1: active drain (N = 82).
Group 2: passive drain (N = 78).
Outcomes Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, readmission, additional radiological intervention, and length of hospital stay.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "we randomized our patients using a computer‐generated random number".
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Quote: "Patients were prospectively assigned a code and data were recorded in a database by two nurses".
Comment: no information provided whether the 2 nurses were blinded.
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: there were no postrandomization dropouts.
Selective reporting (reporting bias) Low risk Comment: all the primary outcomes were reported. There was some selective outcome reporting in the secondary outcomes, but the review authors considered this trial to be free of selective reporting for the primary outcomes.
Other bias Low risk Comment: the study appeared to be free of other sources of bias.