Celik 2010.
Methods | Single‐centre RCT Setting: Department of Neurosurgery, Beyoglu State Hospital, Istanbul Country: Turkey Period: July 2001 to May 2003 |
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Participants |
Number: 80 patients (40/40) Diagnosis: dynamic x‐rays, thin‐sliced CT and MRI; severe back/leg pain and neurogenic claudication; anteroposterior diameter less than 10 mm of the lumbar spinal canal by CT scan and MRI Included: patients who had not responded to conservative medical therapy and physical therapy; more than 41% in ODI; more than 7 in VAS pain; walking distance less than 30 meters; severe lumbar spinal stenosis clinically Excluded: patients requiring discectomy or showing any kind of instability before the surgery Age (years): mean (SD) 61 (13)/59 (14) |
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Interventions |
Group 1: total laminectomy Group 2: bilateral micro decompressive laminotomy. Medial facetectomy and wide foraminotomies were performed at the level of stenosis, preserving the lateral aspect of the facet joints. No patient received discectomy. Follow‐up: 60 months |
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Outcomes |
Pain: 10 cm VAS leg pain Disability: ODI, walking distance Operation time Perioperative blood loss Complications Reoperations |
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Notes |
Surgeon's experience: "both groups of patients were operated by the same senior surgeon in the same time period" 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) | Unclear risk | Quote: "a chart system was used to process randomizaton". |
Allocation concealment (selection bias) | Low risk | Quote: "a registered nurse informed surgeons about the type of surgery before the operation". |
Blinding of participants (performance bias) All outcomes | Low risk | Quote: "patients were not informed as which group they would be placed". |
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: "the patients were preoperative examined and followed at regular intervals by the operating neurosurgeons and by a neurology specialist blinded to the study protocol." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 71/80 = 89% 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 | It was clear that the published report included all expected outcomes. |
Group similarity at baseline (selection bias) | Low risk | There were no preoperative differences between groups, based on Tables 1 to 3. |
Co‐interventions (performance bias) | Low risk | Only the surgical technique differed between treatment groups. |
Compliance (performance bias) | Low risk | Compliance in both treatment groups: 100% (surgery). |
Timing of outcome assessment (detection bias) | Unclear risk | All important outcome assessments for both groups were measured at the same time. |
Other bias | Unclear risk | Conflict of interest and financial support were not reported in this study. |