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 |
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| 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 |
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| Interventions | Intervention group: minimally invasive cardiac surgery (a small skin incision) Control group: conventional cardiac surgery |
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| 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. |
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| 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. |