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Clinical Trials/NCT03740633
NCT03740633
Unknown
Phase 3

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 site in 1 country398 target enrollmentNovember 10, 2018

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Ankle Motion
Sponsor
Lei Li
Enrollment
398
Locations
1
Primary Endpoint
deep venous thrombosis
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2018
End Date
November 10, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not meeting all of the inclusion criteria
  • Delayed extubation

Outcomes

Primary Outcomes

deep venous thrombosis

Time Frame: One years

incidence of deep venous thrombosis

Secondary Outcomes

  • patient satisfaction(One year)
  • adverse events(One year)

Study Sites (1)

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