Bassi 2010

Methods	Randomized controlled trial.
Participants	Country: Italy. Number randomized: 114. Postrandomization dropout: 0 (0%). Mean age: 56.6 years. Females: 55 (48.2%). Pancreatic cancer: 56 (49.1%). Biliary cancer: 2 (1.8%). Ampullary cancer: 7 (6.1%). Chronic pancreatitis: 3 (2.6%). Other: 46 (40.4%). Pancreaticoduodenectomy: 75 (65.8%). Distal pancreatectomy: 39 (34.2%). Other pancreatic surgery: 0 (0%). Inclusion criteria: Participants had undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy. An amylase value in drains on postoperative day 1 < 5000 IU/L. Exclusion criteria: Reconstruction of the pancreatic remnant by pancreaticogastrostomy. Clinical suspicion of postpancreatectomy haemorrhage or relaparotomy within 72 hours from index operation. Appearance of drain effluent or clinical suspect of biliary fistula within 72 hours of index operation. Peripancreatic fluid collection > 5 cm (maximum diameter) at a routine transabdominal ultrasound performed.
Interventions	Participants (N = 114) were randomly assigned to 1 of 2 groups. Group 1: early drain removal (postoperative day 3) (N = 57). Group 2: late drain removal (postoperative day 5 or later) (N = 57).
Outcomes	Pancreatic fistula, abdominal complications, pulmonary complications, reoperation, length of hospital stay, hospital readmission, postoperative mortality, morbidity, and hospital costs.
Notes	2 drainage tubes (Penrose drains) were placed in relation to the pancreatic and biliary anastomoses through separate skin incisions after pancreaticoduodenectomy. 1 drainage tube was placed in relation to the pancreatic stump through separate skin incisions after distal pancreatectomy.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "eligible patients were randomized by a computer‐generated allocation schedule".
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Masking: Open Label" in the protocol.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were no postrandomization dropouts.
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 appeared to be free of other sources of bias.