The Effects of Post-operative Functional Training on the Prevention of Deep Venous Thrombosis in the Patients of Gynecological Malignancies: A Phase 3 Randomized Control Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- deep venous thrombosis
研究概览
简要总结
This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.
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
- Single (Outcomes Assessor)
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
- •Having received major surgeries for gynecologic malignancies
- •Good performance status
- •Aged 18 years or older
- •Signed an approved informed consents
- •No injuries to the skin, musculoskeletal system
- •No venous thromboembolic disease before surgeries
排除标准
- •Not meeting all of the inclusion criteria
- •Delayed extubation
研究组 & 干预措施
Study group
Patients in the study group accept functional training and regular care.
干预措施: passive ankle pump motions on the day of surgery (Behavioral)
Study group
Patients in the study group accept functional training and regular care.
干预措施: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery (Behavioral)
Study group
Patients in the study group accept functional training and regular care.
干预措施: Regular care (Combination Product)
Control group
Patients in the control group only accept regular care.
干预措施: Regular care (Combination Product)
结局指标
主要结局
deep venous thrombosis
时间窗: One years
incidence of deep venous thrombosis
次要结局
- patient satisfaction(One year)
- adverse events(One year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital