Lesurtel 2005.
Methods | Randomised clinical trial. Generation of the allocation sequence: urn randomisation (adequate). Allocation concealment: sealed envelope (adequate). Blinding: inadequate. Incomplete outcome data addressed:adequate. Free from selective reporting: adequate. Free from baseline imbalance bias: adequate. Free from early stopping bias: adequate.Free from sponsor bias: inadequate. |
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Participants | Country: Switzerland.
Number randomised: 100.
Mean age: 56 years.
Females: 47(47%).
Major liver resection: 61(61%).
Chronic liver disease: not stated.
Cirrhosis: none. Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to four groups. Group 1: CUSA (n = 25) Group 2: Hydrojet (n = 25) Group 3: RFDS (n = 25) Group 4: Clamp‐crush (n = 25). Co‐interventions
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Outcomes | The main outcome measures were peri‐operative mortality, peri‐operative morbidity, blood loss and transfusion requirements, liver function tests, transection speed, stay, and costs. | |
Notes | Authors provided information on allocation sequence generation; and questions related to morbidity and liver enzymes in December 2006. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | A ‐ Adequate ("The generation of the randomisation sequence was performed with sealed envelopes using urn randomisation") |
Allocation concealment? | Low risk | A ‐ Adequate ("The generation of the randomisation sequence was performed with sealed envelopes using urn randomisation") |
Blinding? All outcomes | High risk | C ‐ Inadequate |
Incomplete outcome data addressed? All outcomes | Low risk | A ‐ Adequate Review authors' comment: No post‐randomisation drop‐outs. |
Free of selective reporting? | Low risk | A ‐ Adequate Review authors' comment: All the important outcomes were reported. |
Free of baseline imbalance bias? | Low risk | A ‐ Adequate |
From from early stopping bias? | Low risk | A ‐ Adequate Review author comment: The sample size calculations were reported and the calculated number of patients were recruited. |
Free from academic bias? | Low risk | A ‐ Adequate Review author comment: No previous publication or conference report of a similar trial by the trial author was identified. |
Free from sponsor bias? | High risk | C ‐ Inadequate ("The authors thank Tyco Healthcare (Mansfield, MA), Erbe (Tubingen, Germany), and TissueLink (Dover, NH) for their sponsorship") |