跳至主要内容
临床试验/NCT01616316
NCT01616316已完成2 期

Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
86
试验地点
1
主要终点
Dose subfascial approach make better result of swallowing function?

研究概览

简要总结

Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •micropapillary thyroid cancer

排除标准

  • •lateral neck lymph node metastasis
  • •severe thyroiditis
  • •reoperation
  • •extrathyroidal extension

研究组 & 干预措施

subfascial flap

Experimental

干预措施: subfascial flap (Procedure)

Subplatysmal flap

Experimental

干预措施: subplatysmal flap (Procedure)

结局指标

主要结局

Dose subfascial approach make better result of swallowing function?

时间窗: Until 1 year follow up

To see the effect of subfascial approach for postthyroidectomy swallowing symptom , we will compare the swallowing function between group I(subfascial approach) and group II(subplatysmal approach) after completion of study(after 1 year f/u). To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.

Dose subfascial approach make better result of voice symptom?

时间窗: Until 1 year follow up

To see the effect of subfascial approach for postthyroidectomy voice function, we will compare the voice function(e.g. hoarseness) between group I(subfascial approach) and group II(subplatysmal approach) after completion of study(after 1 year f/u). To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.

次要结局

  • The efficacy of subfascial approach in thyroid cancer(Until 1 year follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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