title: Efficacy and safety of thromboembolism prophylaxis with fondaparinux in Japanese colorectal cancer patients undergoing laparoscopic surgery: A phase II study.
abstract: OBJECTIVE
  We aimed to assess the safety and efficacy of fondaparinux (FPNX) for patients undergoing laparoscopic colorectal surgery (LAC).
  
  
  METHODS
  Patients scheduled for LAC received once-daily subcutaneous injections of FPNX 1.5-2.5 mg for 4-8 days. The primary endpoint was the incidence of bleeding events. The secondary endpoint was the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE).
  
  
  RESULTS
  Among 128 patients evaluable for efficacy, 119 patients were administered FPNX. Nine patients were excluded owing to intraoperative events, including conversion to open surgery among others. Thirteen patients discontinued treatment owing to anastomotic bleeding (n = 5), anastomotic leakage (n = 3), bleeding at drain insertion site (n = 2), subcutaneous bleeding (n = 1), drug-induced rash (n = 1), and sepsis (n = 1). Among the FPNX discontinuations, there were eight cases of bleeding (6.7%), and two cases of major bleeding (1.7%). In multivariate analysis, operative time >300 min was identified as a risk factor for bleeding events (p = 0.001) secondary to FPNX. The incidence rate of DVT was 2.5% (3/119 cases); these patients were asymptomatic.
  
  
  CONCLUSIONS
  There were no cases of PE. It is necessary to establish strict criteria for VTE prophylaxis with FPNX after LAC for Japanese patients considering the incidence of bleeding events.
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan. Electronic address: tokuhark@takii.kmu.ac.jp.
authors.forename: Katsuji
authors.initials: K
authors.lastname: Tokuhara
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Matsushima
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Ueyama
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Nakatani
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yoshioka
authors.affiliation: Kansai Medical University, Department of Surgery, 10-15 Fumizonocho, Moriguchi, Osaka, 570-8507, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Kon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000601:surgery*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D013923:Thromboembolism / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000517:prevention & control
chemical_list: D065427:Factor Xa Inhibitors; D011134:Polysaccharides; D000077425:Fondaparinux
keywords: Colorectal cancer; Deep vein thrombosis; Doppler ultrasound; Fondaparinux; Venous thromboembolism