Aalders 1992.
Methods | Site: Femoral to AK popliteal Study design: Single‐centre RCT Method of randomisation: sealed envelopes Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: none |
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Participants | Country: Holland No. of participants: 85 patients(93 limbs; 46 PTFE, 47 HUV) Age: 64 yrs Sex: 67 male, 18 female DM 16, critical 17 Inclusion criteria: AK femoro‐popliteal graft for IC (or limb salvage if vein unavailable) Exclusion criteria: those with previous femoro‐popliteal graft |
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Interventions | 6 mm PTFE versus 6 mm HUV | |
Outcomes | Primary patency, secondary patency, complications | |
Notes | All had post‐op anticoagulants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random permuted blocks" |
Allocation concealment (selection bias) | Unclear risk | Not specifically stated. Probably not done |
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 | Unclear risk | Some patients lost to follow‐up early on, but clear life table data |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other obvious bias |