| Methods |
Patients were randomised using a randomly generated number pattern. Method used to conceal treatment allocation was not described. Blinding was not reported. |
| Participants |
124 patients undergoing elective pancreaticoduodenectomy were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 58), M/F = 37/58, mean age (+/‐SD) = 64 (15.2) years.
(2) Control group (n = 66), M/F = 40/66, mean age (+/‐SD) = 64 (16.2) years. |
| Interventions |
(1) Fibrin sealant group received 8 ml of fibrin sealant applied through a double‐barrel syringe connected to a 'y'‐shaped catheter. The FS was applied circumferencially to the entire anastomosis after the completion of all 3 anastomosis.
(2) Control group did not receive fibrin sealant treatment. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml).
Mortality (n).
Wound infection (n).
Re‐operation (n).
Length of hospital stay (days).
Pancreatic fistula (n). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Random number generator |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
Unclear risk |
Not reported |
