Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- degree of pain
研究概览
简要总结
Postoperative pain is a good indicator to confirm the advantages of the surgical methods in the era of minimally invasive surgery. Lateral neck dissection requires extensive dissection which may leads to postoperative numbness and pain. Robotic thyroid surgery has the advantage of precise and careful dissection and avoid the L-shape incision in the open approach. The study aims to explore the pain intensity and severity of lateral neck dissection on operation day, postoperative month 1 and postoperative month 3 among the robotic, endoscopic and open approach.
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 underwent lateral neck dissection via robotic, endoscopic or open approach
- •Clinical diagnosis of differentiated thyroid cancer
- •Clinical diagnosis of metastatic lateral lymph nodes
排除标准
- •Participants with distant metastasis
- •Participants with history of neck surgery or radiation
- •Participants with vocal fold fixation by preoperative fibrolaryngoscope
研究组 & 干预措施
Open group
Patients underwent lateral neck dissection via open approach
干预措施: Observations on postoperative pain intensity (Other)
Endoscopic group
Patients underwent lateral neck dissection via endoscopic approach
干预措施: Observations on postoperative pain intensity (Other)
Robotic group
Patients underwent lateral neck dissection via robotic approach
干预措施: Observations on postoperative pain intensity (Other)
结局指标
主要结局
degree of pain
时间窗: approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
Number of participants with recurrent laryngeal nerve injury
时间窗: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Number of participants with hypoparathyroidism
时间窗: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
次要结局
未报告次要终点
研究者
Ling Zhan
Principal Investigator
Shanghai 6th People's Hospital
