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临床试验/NCT01726907
NCT01726907撤回不适用

A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach

Yonsei University2 个研究点 分布在 1 个国家开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
length of incision

研究概览

简要总结

Traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (SMG). However, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our previous feasibility study of robot-assisted SMG resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. In addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature.

In this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted SMG resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)

排除标准

  • Past history of neck surgery or radiation
  • Possible malignancy expected from FNAB or image study
  • Gland with severe adhesion to surrounding tissue on preoperative physical examination

结局指标

主要结局

length of incision

时间窗: expected average opeartion time : 60~90 minutes

length of incision is measure by a surgical ruler after before skin incision

次要结局

  • amount and duration of drainage(on the day of discharge from hospital (expected average period : postoperative 3 days))
  • hospital stay(on the day of discharge from hospital (expected average period : postoperative 3 days))
  • complications(on the day of discharge from hospital (expected average period : postoperative 3 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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