| Methods |
Randomised clinical trial |
| Participants |
Country: Brazil
Sample size: 35
Post‐randomisation drop‐out: not stated
Revised sample size: 35
Females: not stated
Mean age: not stated
Malignancy: not stated
Chronic pancreatitis: 0 (0%)
Pancreatoduodenectomy: 35 (100%)
Inclusion criteria:
1. People undergoing pancreaticoduodenectomy
2. Abdominal drain fluid containing amylase > 1000 IU/dL on the first postoperative day |
| Interventions |
The participants were randomised to 2 groups
Group 1: somatostatin analogue (n = not stated)
Further details: octreotide 100 μg sc 3 times daily for 10 days
Group 2: control (n = not stated) |
| Outcomes |
The outcomes reported were proportion of participants with pancreatic fistula and hospital stay |
| Notes |
Pancreatic fistula definition: drain output of any measure volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the serum amylase (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 such as clinically significant pancreatic fistulae were not reported |
| Free of source of funding bias? |
Unclear risk |
Comment: this information was not available |
