Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- intraoperative parathormone values
研究概览
简要总结
The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.
详细描述
Intraoperative PTH values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy.
Postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively.
Other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
排除标准
- •refusal to participate
结局指标
主要结局
intraoperative parathormone values
时间窗: intraoperative
parathormone in pg/mL
次要结局
- postoperative hypocalcemia(within 1 week after thyroidectomy)
- permanent postoperative hypoparathyroidism(at one year after thyroidectomy)
- postoperative hypoparathyroidism(within 1 week after thyroidectomy)
- laryngeal nerve palsy(at one year after thyroidectomy)
- Postoperative complications other than outcomes from 1 to 8(at one year after thyroidectomy)
- permanent postoperative hypocalcemia(at one year after thyroidectomy)
研究者
Laurent BRUNAUD
Professor of Surgery, MD, PhD
Central Hospital, Nancy, France