Beguiristain 1995.
Methods | Randomised clinical trial (parallel design) | |
Participants | Country: Spain
Sample size: 35
Post‐randomisation drop‐out: not stated
Revised sample size: 35
Females: 10 (28.6%)
Mean age: 59.4 years
Malignancy: 30 (85.7%)
Chronic pancreatitis: 3 (8.6%)
Pancreatoduodenectomy: 35 (100%)
Follow‐up: not reported Inclusion criteria: 1. Pancreaticoduodenectomy |
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Interventions | The participants were randomly assigned to 2 groups Group 1: somatostatin (n = 21) Further details: continuous infusion 4.5 mg/day starting immediately after surgery for 7 days Group 2: control (n = 14) | |
Outcomes | The outcomes reported were mortality and perioperative morbidity | |
Notes | Pancreatic fistula definition: drainage of at least 10 mL of fluid with an amylase concentration of more than 5 Somogyi units (grade A) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: this information was not available |
Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: blinding was probably not performed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: this information was not available |
Selective reporting (reporting bias) | High risk | Comment: some important outcomes were not reported |
Free of source of funding bias? | Unclear risk | Comment: this information was not available |