Klinkert 2003.
Methods | Site: Femoral to AK popliteal Study design: RCT Method of randomisation: concealed randomisation using computer generated randomisation envelopes Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: 11 (7%) |
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Participants | Country: the Netherlands Setting: hospital No. of participants: 136 (151 limbs; 75 Saphenous vein, 76 PTFE) Age (median): 69 yrs Gender: 88 males, 48 females Inclusion criteria: severe claudication, rest pain, tissue loss Exclusion criteria: patients with earlier bypass or previously removed long saphenous vein |
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Interventions | 6 mm PTFE and reversed vein graft Oral warfarin from one day pre‐op continued for 6 months. 38 mg aspirin afterwards |
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Outcomes | Primary and secondary patency 5‐year follow up |
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Notes | No compliance checks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear. No specific description |
Allocation concealment (selection bias) | Low risk | Quote: "randomization took place with closed envelope allocation." |
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 | 13 patients lost to long term follow up, clearly described |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | Oral warfarin from one day pre‐op continued for 6 months. 38mg aspirin afterwards |