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临床试验/NCT03740633
NCT03740633Unknown3 期

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

Lei Li1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2018年11月10日最近更新:
适应症

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

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

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

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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