Arita 2005.
Methods | Randomised clinical trial. Generation of the allocation sequence: computerised minimisation process (adequate). Allocation concealment: held by third party (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: adequate. |
|
Participants | Country: Japan.
Number randomised: 80.
Median age: 66 (RFDS); 68 (clamp‐crush).
Females: 20 (25%).
Major liver resection: 20 (25%).
Chronic liver disease: 43 (53.8%).
Cirrhosis: 21 (26.3%). Inclusion criteria
Exclusion criteria Inflow occlusion at the hepatic hilum proved impossible at laparotomy. |
|
Interventions | Participants were randomly assigned to two groups. Group 1: RFDS (n = 40) Group 2: Clamp‐crush (n = 40). Co‐interventions
|
|
Outcomes | The main outcome measures were peri‐operative mortality, peri‐operative morbidity, blood loss and transfusion requirements, liver function tests, transection speed, and hospital stay. | |
Notes | We requested further information from the authors regarding some outcomes in December 2006. We were unable to obtain the information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | A ‐ Adequate ("The assignments were done by an internet‐accessed registration system administered by the independent randomization service") |
Allocation concealment? | Low risk | A ‐ Adequate ("The assignments were done by an internet‐accessed registration system administered by the independent randomization service") |
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? | Low risk | A ‐ Adequate ("This work was supported by a grant from the Kanae Foundation for Life‐Socio‐medical service") |