Bonacchi 2002.
| Study characteristics | ||
| Methods |
Study design: prospective randomised controlled study Duration: 2 years No. of centres: single Location: Italy Setting: cardiac surgery centre Withdrawals: none Dates: January 1999 to July 2001 |
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| Participants | 80 consecutive participants with aortic valve pathology undergoing elective aortic valve replacement. Exclusion criteria: emergent surgery, concomitant coronary revascularisation, left ventricular ejection fraction < 25% or heavily calcified aorta Demographics[limited / full sternotomy] Number of participants: 80 [40/40] Mean age (± SD): [62.6 ± 9.5 years / 64 ± 12.4 years] Gender: not stated Pathophysiology (AS:AR:mixed): [12:8:20 / 10:7:23] Severity of disease (NYHA status): [2.7 ± 0.9 / 2.5 ± 0.7] Mean risk score: not stated Mean left ventricular ejection fraction: [57 ± 12 / 56 ± 13] Diabetes mellitus: not stated Preoperative lung function: not stated Smoking status: not stated |
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| Interventions |
Limited sternotomy: reversed C‐ or reversed L‐shaped sternal incision with < 10 cm skin incision Modifications from full sternotomy: none stated |
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| Outcomes |
Primary outcomes: not stated Secondary outcomes: not stated Other reported outcomes: in‐hospital death, re‐exploration for bleeding, mean mediastinal drainage or bleeding > 800 mL, blood transfusion, atrial fibrillation, atelectasis, respiratory insufficiency, sternal wound infection, sternal instability, mechanical ventilation time, oxygen requirements (pre‐ and postextubation), pain scores (1 and 12 hours), analgesia requirements, ICU stay, hospital stay, spirometry (5 days and 1 to 2 months) (follow‐up time in parentheses) |
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| Standard care | Standard care was normothermic CPB and aortic cross‐clamping with aortic and right atrial 2‐stage venous cannulation. Retrograde and ostial antegrade cold blood cardioplegia were given. A right superior pulmonary vent was used in all cases. Transverse or oblique aortotomies were utilised depending on valve choice rather than surgical approach. Transoesophageal echocardiography was employed in all cases | |
| Notes | No funding or conflict of interests declared. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
| Blinding of outcome assessment (detection bias) Low risk from non‐blinding (objective measures) | Low risk | Mortality, blood loss, deep sternal wound infection, re‐exploration, and postoperative atrial fibrillation rates are unlikely to be affected by absence of blinding. |
| Blinding of outcome assessment (detection bias) At risk from non‐blinding (subjective measures) | Low risk | Participants and staff blinded to surgical incision |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants reported on |
| Selective reporting (reporting bias) | Low risk | Relevant outcome measures reported |
| Other bias | Unclear risk | Limited description of preoperative participant characteristics |