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Efficacy and safety of enoxaparin for preventing venous thromboembolic events after laparoscopic colorectal cancer surgery: a randomized-controlled trial (YCOG 1404).
Surg Today 2019ST

Abstract

PURPOSE

We conducted a prospective study to evaluate the efficacy and safety of postoperative enoxaparin for the prevention of venous thromboembolism (VTE) after laparoscopic surgery for colorectal cancer (LAC) in Japanese patients.

METHODS

The subjects of this multicenter, open-label randomized-controlled trial were 121 patients who underwent LAC between September 2015 and May 2017. The patients were randomly allocated to receive intermittent pneumatic compression (IPC) with enoxaparin (20 mg, twice daily), started 24-36 h after surgery and continued until discharge (Enoxaparin group; n = 61), or IPC alone (IPC group; n = 60). The primary endpoint was the incidence of VTE on day 28 after surgery. The safety outcome was the incidence of any bleeding during treatment and follow-up.

RESULTS

The incidence of VTE on day 28 after surgery was 12.3% (7/57 patients) in the enoxaparin group and 11.9% (7/59 patients) in the IPC group ((p = 1.00). One of the 57 patients (1.8%) in the enoxaparin group and none in the IPC group experienced a bleeding event.

CONCLUSIONS

It may be unnecessary to give enoxaparin to all Japanese patients for the prevention of VTE after LAC. The UMIN Clinical Trials Registry number was UMIN000018633.

Authors+Show Affiliations

Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, YokohamaYokohama, Kanagawa, 232-0024, Japan. nabe-jun@comet.ocn.ne.jp.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Surgery, Yokosuka Kyosai Hospital, 1-16 Yonegahamadori, Yokosuka, Kanagawa, 238-8558, Japan.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, YokohamaYokohama, Kanagawa, 232-0024, Japan.Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31385041

Citation

Nakagawa, Kazuya, et al. "Efficacy and Safety of Enoxaparin for Preventing Venous Thromboembolic Events After Laparoscopic Colorectal Cancer Surgery: a Randomized-controlled Trial (YCOG 1404)." Surgery Today, 2019.
Nakagawa K, Watanabe J, Ota M, et al. Efficacy and safety of enoxaparin for preventing venous thromboembolic events after laparoscopic colorectal cancer surgery: a randomized-controlled trial (YCOG 1404). Surg Today. 2019.
Nakagawa, K., Watanabe, J., Ota, M., Suwa, Y., Suzuki, S., Suwa, H., ... Endo, I. (2019). Efficacy and safety of enoxaparin for preventing venous thromboembolic events after laparoscopic colorectal cancer surgery: a randomized-controlled trial (YCOG 1404). Surgery Today, doi:10.1007/s00595-019-01859-w.
Nakagawa K, et al. Efficacy and Safety of Enoxaparin for Preventing Venous Thromboembolic Events After Laparoscopic Colorectal Cancer Surgery: a Randomized-controlled Trial (YCOG 1404). Surg Today. 2019 Aug 5; PubMed PMID: 31385041.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of enoxaparin for preventing venous thromboembolic events after laparoscopic colorectal cancer surgery: a randomized-controlled trial (YCOG 1404). AU - Nakagawa,Kazuya, AU - Watanabe,Jun, AU - Ota,Mitsuyoshi, AU - Suwa,Yusuke, AU - Suzuki,Shinsuke, AU - Suwa,Hirokazu, AU - Momiyama,Masashi, AU - Ishibe,Atsushi, AU - Saigusa,Yusuke, AU - Yamanaka,Takeharu, AU - Kunisaki,Chikara, AU - Endo,Itaru, Y1 - 2019/08/05/ PY - 2019/04/09/received PY - 2019/07/06/accepted PY - 2019/8/7/entrez KW - Colorectal cancer KW - Enoxaparin KW - Laparoscopic surgery KW - Thromboprophylaxis KW - Venous thromboembolism JF - Surgery today JO - Surg. Today N2 - PURPOSE: We conducted a prospective study to evaluate the efficacy and safety of postoperative enoxaparin for the prevention of venous thromboembolism (VTE) after laparoscopic surgery for colorectal cancer (LAC) in Japanese patients. METHODS: The subjects of this multicenter, open-label randomized-controlled trial were 121 patients who underwent LAC between September 2015 and May 2017. The patients were randomly allocated to receive intermittent pneumatic compression (IPC) with enoxaparin (20 mg, twice daily), started 24-36 h after surgery and continued until discharge (Enoxaparin group; n = 61), or IPC alone (IPC group; n = 60). The primary endpoint was the incidence of VTE on day 28 after surgery. The safety outcome was the incidence of any bleeding during treatment and follow-up. RESULTS: The incidence of VTE on day 28 after surgery was 12.3% (7/57 patients) in the enoxaparin group and 11.9% (7/59 patients) in the IPC group ((p = 1.00). One of the 57 patients (1.8%) in the enoxaparin group and none in the IPC group experienced a bleeding event. CONCLUSIONS: It may be unnecessary to give enoxaparin to all Japanese patients for the prevention of VTE after LAC. The UMIN Clinical Trials Registry number was UMIN000018633. SN - 1436-2813 UR - https://www.unboundmedicine.com/medline/citation/31385041/Efficacy_and_safety_of_enoxaparin_for_preventing_venous_thromboembolic_events_after_laparoscopic_colorectal_cancer_surgery:_a_randomized-controlled_trial_(YCOG_1404) L2 - https://dx.doi.org/10.1007/s00595-019-01859-w DB - PRIME DP - Unbound Medicine ER -