Van Buren 2014

Methods	Randomized controlled trial.
Participants	Country: USA. Number randomized: 137. Postrandomization dropout: 3 (2.2%). Mean age: 63.2 years. Females: 62 (45.3%). Pancreatic cancer: 67 (48.9%). Biliary cancer: not mentioned. Duodenal cancer: not mentioned. Ampullary cancer: 17 (12.4%). Chronic pancreatitis: 15 (10.9%). Pancreaticoduodenectomy: 137 (100%). Distal pancreatectomy: 0 (0%). Other pancreatic surgery: 0 (0%). Inclusion criteria: Participant had a surgical indication for distal pancreatectomy. In the opinion of the surgeon, the participant had no medical contraindications to pancreatectomy. Aged ≥ 18 years. The participant was willing to consent to randomization to the intraperitoneal drain versus no drain groups. The participant was willing to comply with 90‐day follow‐up and answer quality‐of‐life questionnaires per protocol. Exclusion criteria: People who refused to be randomized. People who withdrew their consent before surgery. People who were found to have unresectable disease at the time of exploration, or had an enucleation, or a total pancreatectomy rather than a pancreaticoduodenectomy.
Interventions	Participants (N = 137) were randomly assigned to 1 of 2 groups. Group 1: drainage (N = 68). Group 2: no drainage (N = 69).
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, readmission, additional radiologic intervention, and length of hospital stay.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed using a computerized randomization system at the coordinating center".
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Masking: open label".
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "There were 3 cases for which the randomization group assignment was inadvertently not followed".
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available. All of the study's prespecified outcomes were reported.
Other bias	Low risk	Comment: the study appears to be free of other sources of bias.