Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
试验速览
- 阶段
- 3 期
- 入组人数
- 1,350
- 试验地点
- 2
- 主要终点
- Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
研究概览
简要总结
The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 yrs
- •With a toxic goiter or not, Graves' disease or thyroid nodule requiring a total thyroidectomy
- •Thyroidectomy under cervicotomy
- •No echographic criteria to suspect a cancer: poorly defined nodules, microcalcifications, cervical nodes
- •Patient covered by social security
- •Patient's informed and written consent
- •Possible follow-up during 6 months
排除标准
- •Minors and adults under guardianship
- •Preoperatively known thyroid cancer by cytology
- •Planned partial thyroidectomy
- •Peri-operatively antiplatelet intake
- •Preoperatively ENT examination (if performed) finding a vocal cords affection
- •Diving goiter (> 3 cm below the sternal notch)
- •Surgery using videoscopy
- •Lack of possible monitoring during the 6 months after surgery
- •History of anterior cervical surgery
- •Pregnancy and breast-feeding
- •hypercalcemia (calcemia> 2.6 mmol/l)
研究组 & 干预措施
ultrasonic scissors
干预措施: Ultrasonic Scissors (Ethicon) (Device)
conventional techniques of haemostasis
clips, ligatures, and bipolar coagulation
干预措施: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips) (Device)
结局指标
主要结局
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
时间窗: Day 2
次要结局
- Operative morbidity(Day 0 to Day 2)
- Medico-economic evaluation(From Day 0 until Month 6)