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临床试验/NCT01488669
NCT01488669Unknown不适用

Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Yonsei University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
Number of Retrieved lymph nodes

研究概览

简要总结

In this study we introduce and evaluate the feasibility of our surgical technique to hide the external scar of neck dissection using the robotic system via a modified facelift or retroauricular approach.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed as squamous cell carcinoma of the oral cavity
  • •no clinically identified cervical lymph node metastasis
  • •surgery as initial treatment

排除标准

  • •suspicious neck metastasis
  • •radiation or chemotherapy before the surgery
  • •past history of neck surgery

研究组 & 干预措施

Robotic neck dissection

Experimental

Robotic neck dissection was performed via modified face lift or retroauricular approach using the robotic arms, while conventional neck dissection was conducted after transverse skin incision from the mastoid tip to the midline.

干预措施: robot assisted neck dissection via retroauricular approach (Procedure)

Conventional neck dissection

Active Comparator

Neck dissection is performed after an external transverse skin incision.

干预措施: Conventional neck dissection (Procedure)

结局指标

主要结局

Number of Retrieved lymph nodes

时间窗: when the pathologist examine the specimen which is within 1 week after operation

Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen

次要结局

  • amount and duration of drainage(daily, 6AM, until the drain is removed at an expected average of 5 days)
  • length of hospital stay(when the patient leaves the hospital at an an expected average of 9 days)
  • satisfaction score(3 months after operation)
  • Operation time(when the dissected specimen is removed from the patient at the average of 78 min for conventional group and 157 min for robot-assisted group)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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