Lupo 2007.
Methods | Randomised clinical trial. Generation of the allocation sequence: random number table (adequate). Allocation concealment: unclear. 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. |
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Participants | Country: Italy.
Number randomised: 51 (1 did not undergo resection because of advanced malignancy noted only during malignancy).
Median age: 62
Females: 14 (28%).
Major liver resection: 21 (42%).
Chronic liver disease: not stated.
Cirrhosis: 7 (14%). Inclusion criteria Curative liver resection for primary or secondary liver cancer. Exclusion criteria Patients not considered eligible for radical treatment after laparotomy. |
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Interventions | Participants were randomly assigned to two groups. Group 1: RFDS (n = 24) Group 2: Clamp‐crush (n = 26). Co‐interventions
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Outcomes | The main outcome measures were peri‐operative mortality, peri‐operative morbidity, transfusion requirements, operating time, and hospital stay. | |
Notes | The trial authors provided information on allocation concealment and location of abscesses in March 2008. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | A ‐ Adequate ("The allocation was performed by random numbers tables with sealed envelopes"). |
Allocation concealment? | Unclear risk | B ‐ Unclear ("The allocation was performed by random numbers tables with sealed envelopes"). However, it was not clear if randomisation was performed using blocks. |
Blinding? All outcomes | High risk | C ‐ Inadequate |
Incomplete outcome data addressed? All outcomes | Low risk | A ‐ Adequate Review authors' comment: One patient who allocated to RFDS group had advanced cancer on laparotomy and did not receive the intervention. However, we think that this post‐randomisation drop‐out was not related to the outcomes. |
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 ("The authors thank the Hospital Service Spa (Aprilia) for helping with the technical development of the devices used") |