Open AccessEfficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery
Author(s) -
Hata Taishi,
Yasui Masayoshi,
Ikeda Masataka,
Miyake Masakazu,
Ide Yoshihito,
Okuyama Masaki,
Ikenaga Masakazu,
Kitani Kotaro,
Morita Shunji,
Matsuda Chu,
Mizushima Tsunekazu,
Yamamoto Hirofumi,
Murata Kohei,
Sekimoto Mitsugu,
Nezu Riichiro,
Mori Masaki,
Doki Yuichiro
Publication year - 2019
Publication title -
annals of gastroenterological surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.308
H-Index - 15
ISSN - 2475-0328
DOI - 10.1002/ags3.12279
Subject(s) - medicine , fondaparinux , perioperative , surgery , incidence (geometry) , intermittent pneumatic compression , randomized controlled trial , clinical endpoint , anticoagulant , laparoscopic surgery , venous thromboembolism , laparoscopy , thrombosis , physics , optics
Aim To investigate the efficacy and safety of anticoagulant prophylaxis to prevent postoperative venous thromboembolism ( VTE ) during laparoscopic colorectal cancer ( CRC ) surgery, which is unknown in Japanese patients. Methods We conducted this randomized controlled trial at nine institutions in Japan from 2011 to 2015. It included 302 eligible patients aged 20 years or older who underwent elective laparoscopic surgery for CRC . Patients were randomly assigned to an intermittent pneumatic compression ( IPC ) therapy group or to an IPC + anticoagulation therapy group. Anticoagulation therapy comprised fondaparinux or enoxaparin for postoperative VTE prophylaxis. Postoperative VTE was diagnosed based on enhanced multi‐detector helical computed tomography. The primary endpoint was VTE incidence, including asymptomatic cases, the secondary endpoint was incidence of major bleeding, and we conducted an intention‐to‐treat analysis. This study is registered in UMINCTR (UMIN8435). Results Postoperative VTE incidence was 5.10% with IPC therapy (n = 157) and 2.76% with IPC + anticoagulant therapy (n = 145; P = .293). We identified no symptomatic VTE cases. The major bleeding rates were 1.27% with IPC alone and 1.38% with the combination ( P = .936). The overall bleeding rates were 7.69% for enoxaparin and 13.6% for fondaparinux ( P = .500), and there were no bleeding‐related deaths. Conclusion Anticoagulant prophylaxis did not reduce the incidence of VTE and the incidence of major bleeding was comparable between the two groups. Usefulness of perioperative anticoagulation was not demonstrated in this study. Pharmacological prophylaxis must be restricted in Japanese patients with higher risk of VTE .