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. 2013 Apr 30;2013(4):CD008370. doi: 10.1002/14651858.CD008370.pub3

Hesse 2005.

Methods Randomised clinical trial (parallel design)
Participants Country: Belgium 
 Sample size: 105 
 Post‐randomisation drop‐out: 0 
 Revised sample size: 105 
 Females: 27 (25.7%) 
 Mean age: 59.5 years 
 Malignancy: 71 (67.6%) 
 Chronic pancreatitis: 26 (24.8%) 
 Pancreatoduodenectomy: 80 (76.2%) 
 Follow‐up: not reported
Inclusion criteria: 
 1. Aged 16‐86 years 
 2. Pancreaticojejunostomy
Interventions The participants were randomly assigned to 2 groups 
 Group 1: octreotide (n = 56) 
 Further details: at the time of operation in a dose of 0.1 mg sc 3 times a day for 7 days 
 Group 2: control (n = 49) 
 Further details: no intervention
Outcomes The outcomes reported were mortality, perioperative morbidity and hospital stay
Notes Pancreatic fistula definition: drainage of more than 100 mL/day of amylase rich fluid which had to be more than 5 times the upper limit of normal serum amylase after day 3 and persisting after postoperative day 7 with raising temperature and pre‐septic conditions (grade B)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "was performed according to a computer generated random list"
Allocation concealment (selection bias) Unclear risk Comment: this information was not available
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote: "single center open label prospectively randomized trial"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: "There were no post‐randomisation drop‐outs"
Selective reporting (reporting bias) High risk Comment: important outcomes like re‐operation and adverse effects of octreotide were not reported
Free of source of funding bias? Unclear risk Comment: this information was not available