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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Hamano 2001.

Study characteristics
Methods Prospective, randomised study
Run‐in period: from April 1997 to December 1998
Study date: 2001
Number of study centres and locations: not specified
Participants Forty‐eight adult patients were included in this study, 27 of whom underwent conventional surgery and 21 MICS.
Mean age: 62.25 years
Sex (female/male ratio): 41.67%
No high‐risk patients
Inclusion criteria: patients who underwent surgery for single valve disease
Exclusion criteria: not specified
Interventions Intervention group: minimally invasive cardiac surgery (a small skin incision)
Control group: conventional cardiac surgery
Outcomes Duration and degree of SIRS, the level of CRP, the operating times, perfusion times or aorta clamp times, mean volume of blood transfusion, infection or organ failure
Blood samples were collected 1 day, 3 days, and 6 days postoperatively.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear randomisation method description is given; however, the two groups had similar baseline characteristics: "of the 48 patients, 21 were randomly selected to undergo MICS".
Allocation concealment (selection bias) Unclear risk No allocation concealment information
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not specified; unfeasible because of the type of intervention; unclear whether it influenced management in the postoperative period and outcomes
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias)
All outcomes Low risk No trial group changes, no withdrawals, and no losses to follow‐up were reported, but no ITT analysis. Data from all the participants were included in the final analysis.
Selective reporting (reporting bias) Low risk All expected outcomes were reported properly.
Other bias Low risk No funding was disclosed.