Postacchini 1993.
Methods | RCT Setting: not reported Country: Italy Period: not reported |
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Participants |
Number: 67 patients (26/9/32) Diagnosis: all patients had plain and flexion‐extension radiographs of the lumbar spine with one or more of myelography, plain or contrast‐enhanced computed tomographic, and magnetic resonance imaging Included: patients with central lumbar stenosis who required surgery Excluded: not reported Age (years): mean (range) 57 (43‐79) |
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Interventions |
Group 1: multiple laminotomies Group 2: scheduled multiple laminotomies converted to total laminectomy Group 3: total laminectomy. Disc excision was performed at a single level in four patients. A unilateral or bilateral intertransverse fusion was performed in four patients with degenerative spondylolisthesis Follow‐up: 3.7 years (2.2‐5.3) |
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Outcomes |
Pain: 100 mm VAS leg pain (radicular symptoms) Operation time Perioperative blood loss Complications |
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Notes |
Surgeon's experience: all the patients were operated on by the senior author. Funding: Conflict of interest and financial support were not reported in this study. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "we aimed to randomise the choice of surgical procedure, but had to allow the protocol to be broken when multiple laminotomy appeared to be inadequate to obtain sufficient decompression." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants (performance bias) All outcomes | Unclear risk | No mention of any attempts to blind the participants. |
Bliding of personnel/ care providers (performance bias) | High risk | The surgeon could not have been blinded to the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "at the latest follow‐up, each patient was interviewed and examined by one of the authors, who was unaware of the type of decompression performed." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 67/70 = 95.7% of the patients completed the follow‐up. The number of drop‐outs is unlikely to affect the results. |
Intention‐to‐treat analysis (attrition bias) | Unclear risk | No information about intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. |
Group similarity at baseline (selection bias) | Unclear risk | No information about patient characteristics at baseline. |
Co‐interventions (performance bias) | High risk | Concomitant discectomy and fusion were performed at different rates between the groups. |
Compliance (performance bias) | Low risk | Compliance in both treatment groups: 100% (surgery). |
Timing of outcome assessment (detection bias) | High risk | Quote: "the mean follow‐up was 3.7 years (2.2 to 5.3)." |
Other bias | Unclear risk | Conflict of interest and financial support were not reported in this study. |