| Study characteristics |
| Methods |
Method of randomisation: artery randomisation with unknown method
Blinded outcome assessment
Cross‐overs: shunt: 35 participants not shunted; no shunt: 10 participants shunted (all participants analysed in original group)
Exclusions during trial: none
Loss to follow‐up: none |
| Participants |
Germany
472 participants, 441 with unilateral operations
Shunt: 250 operations
No shunt: 253 operations
Age: mean 64 years
Gender: 70% male, 30% female
Comparability: age, gender, vascular risk factors, indication for operation, degree of ipsilateral/contralateral stenosis in each group not given
Overall: all had ipsilateral stenosis > 70% (20% asymptomatic); 20% had contralateral stenosis > 80%. |
| Interventions |
Treatment: Javid shunt
Control: no shunt (shunted if significant changes on monitoring)
All operations done under general anaesthetic with EEG/SEP monitoring; at end of operation plication, resection, vein interposition were performed to achieve laminar flow on Doppler. |
| Outcomes |
Death plus stroke‐related death, any stroke (during the operation and within 30 days), ipsilateral stroke, haemorrhage from operation site, infection at operation site |
| Notes |
Exclusions: bilateral simultaneous endarterectomies, simultaneous reconstruction of supra‐aortic branch and carotid bifurcation
Follow‐up: 30 days |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "the use of the intraluminal Javid shunt was prospectively randomised in a continuous series of 503 CEs". However, the random method was not specified. |
| Allocation concealment (selection bias) |
Low risk |
The author mentioned that the allocation concealment was administered using opaque, sequentially‐numbered sealed envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Based on unpublished data, a neurologist who was blinded to treatment allocation assessed participants postoperatively. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Based on unpublished data, there was no loss to follow‐up in this study. |
| Selective reporting (reporting bias) |
Unclear risk |
Study authors did not report prespecified outcome. |
| Other bias |
High risk |
Possible biases included unequal cross‐over shunting number between groups, not to mention the possible sources of bias (i.e. age, gender, and vascular risk factors), imbalance in a surgical technique (patching in shunting (56%) versus no shunting (39%)), imbalance in number of experienced surgeon between groups, and included bilateral endarterectomy. |
