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. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2

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.
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.
Interventions Participants were randomly assigned to two groups.
Group 1: RFDS (n = 24) 
 Group 2: Clamp‐crush (n = 26).
Co‐interventions
  1. Vascular occlusion: no vascular occlusion.

  2. Low CVP: not stated.

  3. Hypoventilation: not stated.

  4. IV agents to decrease blood loss: not stated.

  5. Management of raw surface: RFDS group ‐ sealing of large vessels was reinforced with stitches. Clamp‐crush group ‐ bipolar diathermy and 3‐0 prolene sutures. Fibrin glue was used in some patients.

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")