Montorsi 1995.
| Methods | Randomised clinical trial (parallel design) | |
| Participants | Country: Italy
Sample size: 278
Post‐randomisation drop‐out: 60
Revised sample size: 218
Females: 87 (39.9%)
Mean age: 58.2 years
Malignancy: 139 (63.8%)
Chronic pancreatitis: 18 (8.3%)
Pancreatoduodenectomy: 143 (65.6%)
Follow‐up: not reported Inclusion criteria: 1. Elective pancreatic resection for neoplastic or chronic inflammatory disease of the pancreas and the periampullary region 2. Aged 18‐75 years 3. ASA I or II Exclusion criteria: 1. People with ongoing acute pancreatitis 2. Treatment with octreotide or native somatostatin within the last 48 h |
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| Interventions | The participants were randomly assigned to 2 groups Group 1: octreotide (n = 111) Further details: 100 μg sc 3 times daily for 7 days starting 1 h before operation Group 2: placebo (n = 107) Further details: equal volume, frequency and duration as intervention | |
| Outcomes | The outcomes reported were mortality and perioperative morbidity | |
| Notes | Reasons for post‐randomisation drop‐out: unresectable (n = 54); protocol violations (n = 6) Pancreatic fistula definition: amylase‐rich fluid (amylase more than 3 times normal serum concentration) collected from the peripancreatic abdominal drainage since the postoperative day 3, with a drainage volume of greater than 10 mL/day (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 | Low risk | Quote: "octreotide or placebo was started in a double‐blind fashion, 1 hour before operation, as follows: 1 ml (100 mcg octreotide or placebo) every 8 hours subcutaneously for 7 days" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: post‐randomisation drop‐outs were related to the outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: important outcomes were reported |
| Free of source of funding bias? | Unclear risk | Comment: this information was not available |