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. 2016 Nov 1;2016(11):CD012421. doi: 10.1002/14651858.CD012421

Postacchini 1993.

Methods RCT
Setting: not reported
Country: Italy
Period: not reported
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)
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)
Outcomes Pain: 100 mm VAS leg pain (radicular symptoms)
Operation time
Perioperative blood loss
Complications
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.
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.