Post 2001.
Methods | Site: Femoral to AK and BK popliteal Study design: RCT Method of randomisation: concealed randomisation using computer generated randomisation envelopes Blinding: unblinded, intention to treat Exclusions post randomisation: 3 (1%) Losses to follow up: 6 (2%) |
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Participants | Country: Germany Setting: hospital No. of participants: 203 (194 limbs analysed. AK: 65 PTFE, 76 Dacron, BK: 26 PTFE, 27 Dacron) Age (median): 66 yrs Sex: 155 males, 48 females Inclusion criteria: severe claudication, rest pain, tissue loss Exclusion criteria: infection, emergency surgery for acute ischaemia, distal anastomosis below anterior tibial origin, concomitant disease not expected to live past 3 years, contraindication to anticoagulants |
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Interventions | PTFE and Dacron (diameter at discretion of operating surgeon) Post‐op warfarin, heparin or antiplatelet agents |
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Outcomes | Primary patency 3‐year follow up |
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Notes | No consistent anticoagulation protocol. No compliance checks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The order of Secondary end‐points assignment had been generated by random digits from a statistical software package (SAS)." |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised to either treatment arm intraoperatively by sealed envelopes." |
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 | No losses, clear life table data |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Unclear risk | No consistent anticoagulation protocol |