OBJECTIVES: The aim of this prospective randomized study was to demonstrate the comparability of retrojugular access for carotid eversion endarterectomy compared to the conventional ventrojugular procedure. PATIENTS AND METHODS: Due to the expected minor and major complication rate of 5% in patients undergoing carotid surgery, a patient cohort of 600 study patients was planned. All patients underwent standard preoperative and postoperative assessment including clinical investigation and fiberoptic laryngoscopy. The 6 month follow-up examination included an evaluation of patient contentment, a duplex scan, clinical investigation and a fiberoptic laryngoscopy. RESULTS: After the first interim evaluation of 101 patients, the study was stopped because of a significant increase in temporary ipsilateral vocal cord motility dysfunction in the retrojugular access group (31% vs. 6%, p=0.0014). This early postoperative impairment was, however, not statistically significant at the follow-up examination at 6 months (2.4% vs. 0%). No other significant differences concerning major complications (death or stroke), other cranial nerve injuries, wound healing, or patient satisfaction was observed neither in the early postoperative phase nor at follow up. CONCLUSION: Due to the high incidence of temporary ipsilateral vocal cord dysfunction in patients undergoing retrojugular exposure of the carotid artery, we recommend the conventional ventrojugular approach, which can be performed by incision along the anterior border of the sternomastoid muscle or by transversal skin incision.
RCT Entities:
OBJECTIVES: The aim of this prospective randomized study was to demonstrate the comparability of retrojugular access for carotid eversion endarterectomy compared to the conventional ventrojugular procedure. PATIENTS AND METHODS: Due to the expected minor and major complication rate of 5% in patients undergoing carotid surgery, a patient cohort of 600 study patients was planned. All patients underwent standard preoperative and postoperative assessment including clinical investigation and fiberoptic laryngoscopy. The 6 month follow-up examination included an evaluation of patient contentment, a duplex scan, clinical investigation and a fiberoptic laryngoscopy. RESULTS: After the first interim evaluation of 101 patients, the study was stopped because of a significant increase in temporary ipsilateral vocal cord motility dysfunction in the retrojugular access group (31% vs. 6%, p=0.0014). This early postoperative impairment was, however, not statistically significant at the follow-up examination at 6 months (2.4% vs. 0%). No other significant differences concerning major complications (death or stroke), other cranial nerve injuries, wound healing, or patient satisfaction was observed neither in the early postoperative phase nor at follow up. CONCLUSION: Due to the high incidence of temporary ipsilateral vocal cord dysfunction in patients undergoing retrojugular exposure of the carotid artery, we recommend the conventional ventrojugular approach, which can be performed by incision along the anterior border of the sternomastoid muscle or by transversal skin incision.