Suc 2004.
Methods | Randomised clinical trial (parallel design) | |
Participants | Country: France
Sample size: 230
Post‐randomisation drop‐out: 0
Revised sample size: 230
Females: 99 (43%)
Mean age: 56.5 years
Malignancy: 154 (67%)
Chronic pancreatitis: 30 (13%)
Pancreatoduodenectomy: 177 (77%)
Follow‐up: not reported Inclusion criteria: 1. Pancreatic resection was performed for either malignant or benign disease 2. Age more than 18 years Exclusion criteria: 1. Resection for acute pancreatitis or trauma 2. Simple tumour excision 3. Total or central pancreatectomy 4. Pancreatoduodenectomy without immediate pancreatodigestive anastomosis 5. Duodenum‐preserving pancreatectomy |
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Interventions | The participants were randomly assigned to 2 groups Group 1: octreotide (n = 122) Further details: 100 μg sc during the operation every 8 h for 10 days Group 2: control (n = 108) Further details: no treatment | |
Outcomes | The outcomes reported were mortality, re‐operation, perioperative morbidity and hospital stay | |
Notes | Pancreatic fistula definition: either chemically as fluid obtained through drains or percutaneous aspiration containing at least 4 times normal serum values of amylase for 3 days, irrespective of the amount of output and the date of appearance or clinically and radiologically as anastomotic leaks (type A, B, C ‐ not available separately) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "allotment to octreotide or not, as generated by computerized random number tables, was decided by a telephone call to the coordinating center which collected and processed all data" |
Allocation concealment (selection bias) | Low risk | Quote: "allotment to octreotide or not, as generated by computerized random number tables, was decided by a telephone call to the coordinating center which collected and processed all data" |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "patients were not aware of the treatment arm to which they were allotted (octreotide injection was considered as part of postoperative treatment), but the surgeon performing the operation, obviously, was (single‐blind study without placebo). Complications, however, were assessed by a physician who was unaware of the allotted treatment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no post‐randomisation drop‐outs |
Selective reporting (reporting bias) | Low risk | Comment: all pre‐defined outcomes were reported |
Free of source of funding bias? | Unclear risk | Comment: this information was not available |