Efficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery

Abstract

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 (UMIN000008435). 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.

Perioperative Short Term Prophylaxis against Deep Vein Thrombosis after Major Abdominal Cancer Surgery: Retrospective Cohort Study

“…It is still controversial whether to administrate extended (4 weeks) or short-term (7-10 days until discharge) PTP in the postoperative period in patients undergoing major abdominal or pelvic cancer surgery ( Table 5 ). In fact, in Eastern populations which have less risk factors than Western counterparts, there are studies favoring for short-term prophylaxis or even observation without prophylaxis, without increasing incidence of VTE [ 25 - 27 ]. In a prospective double-arm study by Lee et al [ 12 ], 548 colorectal cancer patients had only mechanical prophylaxis such as anti-embolism stockings or elastic bandages without using PTP in the perioperative period.…”

Incidence of postsurgical pulmonary embolism and deep venous thrombosis: a single-center retrospective observational study

“…Routine screening with Doppler ultrasonography revealed that the DVT incidence after colorectal surgery was 3.0% [6]. Another study reported that DVT/PE incidence among laparoscopic colorectal surgery patients without anticoagulant prophylaxis was 5.1% using enhanced CT screening for all patients [7]. Higher incidence of DVT/ PE is reported in laparoscopic surgery for gastrointestinal cancer as 18.3% [9], and 24.3% in major abdominal surgery [10].…”

“…We compared the incidence of DVT/PE between acute appendicitis and other disease categories. Then, we compared the background data (operative time and age) between patients with acute appendicitis and those with colorectal cancer, as asymptomatic DVT/PE incidence among colorectal cancer patients had been well studied [6,7], and the number of operated cases are much higher in colorectal cancer than in other cancers. We thought DVT/PE incidence among colorectal cancer patients may provide a benchmark.…”

2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19

“…Five small Japanese randomised controlled trials assessed mechanical methods of thromboprophylaxis in surgical patients with cancer, with inconsistent findings. 44 , 45 , 46 , 47 , 48 In a network meta-analysis of patients with gynaecological cancer undergoing major abdominopelvic surgery, comparing different methods of thromboprophylaxis, intermittent pneumatic compression plus LMWH was best for VTE prevention. 42 …”