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 |
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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 |