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Annals of Surgical Oncology

, Volume 21, Issue 13, pp 4232–4238 | Cite as

Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients: An Interim Analysis of Prospective Randomized Trial

  • Kyo Young SongEmail author
  • Han Mo Yoo
  • Eun Young Kim
  • Ji-Il Kim
  • Hyeon Woo Yim
  • Hae Myung Jeon
  • Cho Hyun Park
Gastrointestinal Oncology

Abstract

Background

Whereas routine prophylaxis for venous thromboembolism (VTE) is frequently utilized in the West, Asian physicians employ it much less often, based on its recorded rarity amongst their patients. This study was designed to examine the incidence of VTE and to determine the optimal method of thromboembolic prophylaxis following gastrectomy for cancer.

Methods

In this prospective, randomized trial, patients were assigned to either an intermittent pneumatic compression (IPC) only or an IPC plus enoxaparin. The primary end point of this study was to determine the VTE incidence rate within 30 days of surgery. A history with physical examinations for VTE and a serum d-dimer test was scheduled on postoperative days (POD) 0, 1, 4, and 7. Duplex ultrasonography (DUS) was performed as an objective test for deep vein thrombosis at POD 4. An interim analysis was performed to determine if it was ethical to continue the study. This clinical trial was registered at www.clinicaltrials.gov (NCT01448746).

Results

Among the 220 patients, 3 (all from the IPC group) were diagnosed with VTE; these cases were asymptomatic, having been detected only on DUS 4 days after surgery. Postoperative bleeding occurred in 12 cases, among which 11 patients were in the IPC plus enoxaparin group.

Conclusions

This interim analysis showed a higher incidence of VTE in the IPC group but a higher bleeding rate in the IPC plus enoxaparin group. We expect that this study, once completed, will provide information key to the determination of the optimal method for preventing VTE in Korean gastric cancer patients.

Keywords

Enoxaparin Gastric Cancer Patient Postoperative Bleeding Intermittent Pneumatic Compression Chronic Venous Insufficiency 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgment

The authors are grateful for the statistics-related consultation provided by the Catholic Research Coordinating Center’s Department of Biostatistics, and also thank Hyun Kyo Kim and Ji Eun Yoo for collection and assembly of data.

Disclosure

This clinical trial was supported by Covidien.

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Copyright information

© Society of Surgical Oncology 2014

Authors and Affiliations

  • Kyo Young Song
    • 1
    Email author
  • Han Mo Yoo
    • 1
  • Eun Young Kim
    • 1
  • Ji-Il Kim
    • 2
  • Hyeon Woo Yim
    • 3
  • Hae Myung Jeon
    • 1
  • Cho Hyun Park
    • 1
  1. 1.Division of Gastrointestinal Surgery, Department of Surgery, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulKorea
  2. 2.Division of Vascular and Transplantation Surgery, Department of Surgery, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulKorea
  3. 3.Clinical Research Coordinating Center of Catholic Medical Center, College of MedicineThe Catholic University of KoreaSeoulKorea

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