Stonebridge 1997.
Methods | Site: Femoral to AK or BK popliteal Study design: multicentre RCT Method of randomisation: central randomisation centre assessment of artery and vein Blinding: unblinded, intention to treat Exclusions post randomisation: not specified Losses to follow up: not stated Protocol violations: none declared |
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Participants | Country: UK Setting: multicentre No. of participants: 246 Inclusion criteria: femoro‐popliteal graft to AK (76 cuff, 74 no cuff) or BK (48 cuff, 47 no cuff) popliteal Exclusion criteria: trauma |
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Interventions | 6 mm PTFE with and without a vein cuff | |
Outcomes | Primary patency, secondary patency, limb salvage | |
Notes | No consistent anticoagulation protocol | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of randomisation technique |
Allocation concealment (selection bias) | Unclear risk | No clear description |
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 | Attrition rates not clearly presented |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Unclear risk | No consistent anticoagulation protocol |