Dogan 2003.
| Study characteristics | ||
| Methods |
Study design: prospective randomised controlled study Duration: not stated No. of centres: single Location: Germany Setting: university hospital Withdrawals: none Dates: not stated |
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| Participants | 40 consecutive participants scheduled for elective aortic valve replacement Exclusion criteria: stentless valves or pulmonary autograft, carotid stenosis > 50%, severe ascending aortic calcification, history of TIA or stroke, Alzheimer's or Parkinson's disease Demographics[limited / full sternotomy] Number of participants: 40 [20 / 20] Mean age (± SD): [65.7 ± 1.9 years / 64.3 ± 2.9 years] Male gender: [9 (45%) / 11 (55%)] Pathophysiology (AS:AR:mixed): [8:3:9 / 6:1:13] Severity of disease mean gradient: [57 ± 14 / 63 ± 15] Mean risk score: not stated Mean left ventricular ejection fraction: [64 ± 3 / 65 ± 2] Diabetes mellitus: [4(20%) / 3(15%)] Preoperative FEV1: [2.3 ± 0.9 / 2.6 ± 0.8] Preoperative FVC: [3.0 ± 1.0 / 3.2 ± 1.0] Smoking status: not stated |
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| Interventions |
Limited sternotomy: limited median skin incision (7 to 9 cm) and reversed L‐shaped upper partial sternotomy into fourth or fifth right intercostal space Modifications from full sternotomy: the venting and cardioplegia strategies in the minimally invasive cases were different. Different surgeons performed minimally invasive and full‐sternotomy operations. |
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| Outcomes |
Primary outcomes: operative time, CPB and cross‐clamp time, postoperative ventilation, 24‐hour chest tube drainage, ICU stay, and hospital stay Secondary outcomes: spirometry (postoperative day 6 or 7), pain scores (days 2 to 3 and 6 to 7), neuropsychological and biochemical tests Other reported outcomes: none (follow‐up time in parentheses) |
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| Standard care | Standard care was propofol anaesthesia, ascending aorta and right atrial cannulation, apical left ventricular vent, antegrade and retrograde cold blood cardioplegia. Right temporary pacing wires | |
| Notes | No conflict of interest or funding | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| 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) | 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 relevant outcome measures reported |
| Other bias | Unclear risk | Some confounding aspects of surgical techniques differing between 2 groups (vent and cardioplegia techniques) |