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临床试验/NCT03048539
NCT03048539Unknown不适用

Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年2月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
试验地点
1
主要终点
Change in quality of life after surgery

研究概览

简要总结

The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.

详细描述

Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.

This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm

排除标准

  • previous neck surgery
  • suspected thyroid carcinoma
  • patient who failure endoscopic thyroidectomy and change to conventional surgery

结局指标

主要结局

Change in quality of life after surgery

时间窗: 2,6,12 weeks

Quality of life will assessed by Short form health survey 36 and specific questionnaire for thyroidectomy. These questionnaires will assess at 2,6 and 12 weeks after surgery. The quality of life results (6 and 12 weeks) will be observed that change from 2 weeks after surgery. Furthermore, investigators will compare score of Short form health survey 36 and specific quality of life questionnaire for thyroidectomy between endoscopic and open technique at 2,6,12 week after surgery, also.

次要结局

  • Postoperative complication(2,6, and 12 weeks)

研究者

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

Pornthep Kasemsiri

Principal investigator

Khon Kaen University

研究点 (1)

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