Gloor 1996.
Methods | Site: Ilio or femoral to AK popliteal Study design: single‐centre RCT Method of randomisation: not explicitly stated Blinding: stated to be single‐blind Exclusions post randomisation: not stated Losses to follow up: none Protocol violations: none stated |
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Participants | Country: France Setting: hospital No. of participants: 18 (20 limbs; 10 PUR graft, 10 Dacron) Age (mean): PUR group: 70.7 years; Dacron: 70.5 years Sex: Overall 13 men, 7 women; PUR group: 6 men, 4 women; Dacron group: 7 men, 3 women Inclusion criteria: peripheral arterial occlusion of lower limb graded Fontaine stage IIb‐IV requiring AK synthetic ilio‐ or femoro‐popliteal bypass Exclusion criteria: obesity, emergency surgery, critical threat to limb |
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Interventions | Iliac or Femoral to AK popliteal bypass graft with either 6 mm PUR or 6 mm Dacron | |
Outcomes | Primary and secondary patency, complications in first 30 days, reintervention rate | |
Notes | Clear anticoagulation/antiplatelet protocol | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated |
Allocation concealment (selection bias) | Unclear risk | Timing of randomisation not declared |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial, though participants were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors not obviously blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No PRISMA flow chart, no mention of patients excluded prior to randomisation or after randomisation |
Selective reporting (reporting bias) | Unclear risk | Primary and secondary patency as well as reinterventions reported, but no complications in first 30 days which did not lead to reintervention mentioned |
Other bias | Low risk | Clear anticoagulation and antiplatelet protocol |