| Study characteristics |
| Methods |
Allocation concealment: unknown
Blinding of outcome assessment: duplex and clinical FU blinding unknown
Cross‐overs: unknown
Exclusions during trial: unknown
Participants lost to FU: unknown |
| Participants |
Country: Italy
Number of participants: 90
Number of operations: 100
Sex (male:female ratio): 6:5
Mean age: unknown
% asymptomatic carotid disease: 10%
% stenosis: unknown
Comparability: age, sex and vascular risk factors not reported by treatment group |
| Interventions |
Treatment: autologous vein or synthetic patch (distribution unknown)
Control: primary closure
% shunted: unknown
Medication: aspirin before surgery, unknown after surgery |
| Outcomes |
Death within 30 days and during FU; stroke within 30 days and during FU; restenosis during FU (DSA) |
| Notes |
Exclusion criteria: unknown
FU: 2 years
Funding sources: none reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random sequence generation not reported. |
| 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 |
Unclear risk |
Number of participants lost to follow‐up not reported. |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether study authors reported the results of all prestated outcomes. |
| Other bias |
Low risk |
None suspected. |
