Solakovic 2008.
| Methods | Site: AK popliteal Study design: single‐centre RCT Method of randomisation: concealed randomisation using sealed envelopes following intraoperative assessment of artery and vein Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: 9 (7%) Protocol violations: none |
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| Participants | Country: 1 centre in Bosnia Setting: hospital No. of participants: 109 patients, 121 limbs (12 patients had a second bypass in the contralateral limb during the study period). There were 60 reversed LSV bypasses and 61 prosthetic bypasses (PTFE or Dacron, material not further specified) Age (median): 70 yrs in reversed LSV group, 68 in prosthetic group Sex: 70 males, 51 females Inclusion criteria: rest pain, tissue loss, 'disabling claudication' Exclusion criteria: previous revascularisation in treated leg, LSV not available or suitable, CFA or AK popliteal not suitable site for anastomosis |
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| Interventions | Reversed LSV or 6 mm prosthetic bypass from CFA to above‐knee popliteal artery | |
| Outcomes | Primary patency, secondary patency | |
| Notes | All patients received prophylactic clexane at a dose of 0.5 ml/kg while in hospital and then 150 mg/day aspirin after discharge. Compliance with this protocol was not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description of randomisation sequence generation technique |
| Allocation concealment (selection bias) | Low risk | Envelope selected at random after confirmation of suitable target vessel and suitable vein |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors and patients not obviously blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 7% of patients lost to follow‐up over 5 years |
| Selective reporting (reporting bias) | Low risk | Stated outcomes reported |
| Other bias | Unclear risk | Consistent anticoagulation protocol but no compliance checks reported |