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临床试验/NCT01126060
NCT01126060已完成3 期

Efficacy of Fibrin Sealant to Reduce the Amount of Postoperative Drain in Patients With Harmonic Scalpel-assisted Total Thyroidectomy With Anterior Compartment Neck Dissections

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
78
试验地点
1
主要终点
Postoperative Drainage Amount

研究概览

简要总结

Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • proven thyroid carcinoma
  • Thyroidectomy with anterior compartment neck dissection

排除标准

  • No use of harmonic scalpel during surgery
  • coagulation abnormality
  • refuse to participate

研究组 & 干预措施

Fibrin sealant

Active Comparator

usage of fibrin sealant after surgery

干预措施: Usage of Fibrin sealant (Drug)

Fibrin sealant

Active Comparator

usage of fibrin sealant after surgery

干预措施: Thyroidectomy (Procedure)

Control

No Intervention

No usage of fibrin sealant

干预措施: Thyroidectomy (Procedure)

结局指标

主要结局

Postoperative Drainage Amount

时间窗: serial measurement from 1day to 4day after surgery

method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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