Optimal Prophylactic Method of Venous Thromboembolism (VTE)
This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients|
- incidence of VTE [ Time Frame: up to 30 days after operation ] [ Designated as safety issue: No ]The incidence of VTE between mechanical method only group and mechnical plus LMWH group.
- Adverse event [ Time Frame: up to 30 days after operation ] [ Designated as safety issue: Yes ]The adverse event such as bleeding will also be compared.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: intermittent pneumatic compression
another arm include intermittent pneumatic compression plus low molecular weight heparin
Drug: low molecular weight heparin
40mg 12 hours before surgery and 12 hours later surgery
Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer.
Gastric cancer is the most frequent cancer in Korea.
The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery.
However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients.
Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis.
The incidence and adverse event will be examined to define the optimal prophylactic method of VTE in surgical patients with gastric cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448746
|Contact: Kyo Young Song, M.D.||+email@example.com|
|Korea, Republic of|
|Seoul St. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 137701|
|Contact: Kyo Young Song, M.D. +82222586106 firstname.lastname@example.org|
|Principal Investigator:||Kyo Young Song, M.D.||The Catholic University of Korea|