Moustafa 2007.
| Methods |
Study design: prospective randomised controlled study Duration: not stated No. of centres:single Location: Egypt Setting: university hospital Withdrawals: none Dates: not stated |
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| Participants | 60 consecutive participants undergoing first‐time elective aortic valve replacement for either AS or AR Exclusion criteria: emergency surgery, left ventricular ejection fraction < 25%, heavily calcified ascending aorta, redo valve surgery, other associated valve lesions Demographics [limited / full sternotomy] Number of participants: 60 [30 / 30] Mean age (± SD): [22.9 ± 2.4 / 23.8 ± 3.5] Male gender: [16 / 15] Pathophysiology (AS:AR): [15:15 / 15:15] Severity of disease: not stated Mean risk score: not stated Mean left ventricular ejection fraction: [56 ± 2.3 / 55 ± 2.6] Diabetes mellitus: not stated Preoperative lung function: not stated Smoking status: not stated |
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| Interventions |
Limited sternotomy: reversed L‐shaped mini‐sternotomy to the 3rd intercostal space Other modifications from full sternotomy: venous drainage not specified in methods but noted to be different for mini‐sternotomy group |
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| Outcomes |
Primary outcomes: not stated Secondary outcomes: not stated Other reported outcomes: pulmonary function tests (1 week and 1 month post), length of incision, operating time, CPB time, ventilation time, chest drainage at 24 hours, blood transfusions, ICU stay, total hospital stay, participant survey of cosmetic effect, analgesia use (follow‐up time in parentheses) |
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| Standard care | Standard care was aortic and right atrial cannulation, coronary ostial and root antegrade cold blood cardioplegia, main pulmonary artery or left atrial appendage venting. All participants received a St Jude Medical mechanical bileaflet prosthesis. | |
| Notes | No conflict of interests declared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Closed envelope method |
| Allocation concealment (selection bias) | Low risk | Closed envelope method |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) Low risk from non‐blinding | 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 | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All cited and relevant outcome measures reported |
| Other bias | Low risk | |