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. 2018 Feb 11;2018(2):CD001487. doi: 10.1002/14651858.CD001487.pub3

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
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
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