NCT00984269进行中（未招募）不适用
Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Lymphedema 15% change from pre-post in girth
研究概览
简要总结
This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.
- •Patients ages 18 and over
- •Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of < 20 minutes.
- •The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.
排除标准
- •Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment
- •Patients under the age of 18
- •Patients who are pregnant
- •Patients presenting for an elective hand procedure with an anticipated tourniquet time of > 20 minutes.
- •Patients who are on a blood thinner which cannot be stopped prior to surgery
- •The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.
结局指标
主要结局
Lymphedema 15% change from pre-post in girth
时间窗: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
次要结局
- Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications(10-14 days, 6 weeks, 3 months, 6 months, and 1 year)
研究者
研究点 (4)
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