| Study characteristics |
| Methods |
Allocation concealment: odd/even social security number (participants randomised)
Blinding of outcome assessment: neither duplex nor clinical FU blind
Cross‐overs: none
Exclusions during trial: none
Participants lost to FU: 12 (12%) |
| Participants |
Country: USA
Number of participants: 87
Number of operations: 100
Sex: 56% male
Mean age: 67 years
% asymptomatic carotid disease: 40%
% stenosis: unknown
Comparability: age, sex, vascular risk factors and % asymptomatic disease similar in each group |
| Interventions |
Treatment: PTFE patch
Control: primary closure
% shunted: routine shunting for all
Medication: postoperative aspirin (325 mg) for all |
| Outcomes |
Death within 30 days and during FU; stroke within 30 days and during FU; perioperative occlusion (duplex); wound haemorrhage, infection, or cranial nerve palsy; restenosis > 50% or occlusion at end of FU (duplex) |
| Notes |
Exclusion criteria: previous endarterectomy, simultaneous cardiac surgery, ICA diameter < 3.5 mm
FU: mean 29 months
Funding sources: none reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Odd/even social security number (participants randomised). |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment method not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding of study participants not reported. Because of the nature of the intervention (patch or primary closure), the surgeon could not be blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of outcome assessment not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
12% of participants lost to follow‐up. |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether study authors reported the results of all prestated outcomes. |
| Other bias |
Low risk |
None suspected. |
