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临床试验/NCT06803732
NCT06803732招募中不适用

Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Zhan

Principal Investigator

Shanghai 6th People's Hospital

研究点 (1)

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