Frilling 2005.
Methods | Randomised clinical trial | |
Participants | Country: European multicentre trial
Number randomised: 121
Postrandomisation dropouts: 0 (0%)
Revised sample size: 121
Average age: not stated
Women: not stated
Number of cirrhotics: not stated
Number of major liver resections: not stated
Number of right hepatectomies: not stated
Follow‐up (months): until discharge
Further details of methods of liver resection
Inclusion criteria: patients undergoing elective liver resection |
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Interventions | Participants were randomly assigned to 2 groups. Group 1: fibrin sealant (n = 59) Group 2: argon beam coagulator (n = 62) Fibrin sealant: Tachosil | |
Outcomes | The outcomes reported were: short‐term mortality, number of serious adverse events, proportion of people with any adverse events, and number of adverse events. | |
Notes | — | |
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 | Quote: "Allocation was concealed by the use of sealed treatment code envelopes, which were opened when the patients had fulfilled the eligibility criteria". Comment: further details of sealed envelope method were not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The trial was open, since the appearance of TachoSil precluded blinding". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The trial was open, since the appearance of TachoSil precluded blinding". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no postrandomisation dropouts. |
Selective reporting (reporting bias) | Low risk | Comment: mortality and morbidity were reported. |
Vested interest bias | Unclear risk | Comment: this information was not available. |
Other bias | Low risk | Comment: no other bias |