NCT03293186已完成4 期
Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
研究概览
简要总结
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned to perform thyroidectomy due to thyroid nodule
- •no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer
- •normal preoperative vocal cord movement
- •normal preoperative laboratory study
排除标准
- •uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy
- •history of keloid or hypertrophic scar
- •Graves disease or hashimoto thyroiditis patients
- •aspirin or anticoagulant medication within 7 days
- •radiation exposure to the head and neck
- •previous operation to the neck
- •history of allergic reaction to drugs
- •pregnant women
结局指标
主要结局
Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
时间窗: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months
次要结局
未报告次要终点
研究者
Su-jin Kim
Associate professor
Seoul National University Hospital
研究点 (2)
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