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

Celik 2010.

Methods Single‐centre RCT
Setting: Department of Neurosurgery, Beyoglu State Hospital, Istanbul
Country: Turkey
Period: July 2001 to May 2003
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)
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
Outcomes Pain: 10 cm VAS leg pain
Disability: ODI, walking distance
Operation time
Perioperative blood loss
Complications
Reoperations
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.
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.