title: Randomized controlled trial of enoxaparin versus intermittent pneumatic compression for venous thromboembolism prevention in Japanese surgical patients with gynecologic malignancy.
abstract: OBJECTIVE
  The aim of this study was to compare the efficacy and safety of enoxaparin and intermittent pneumatic compression (IPC) for venous thromboembolism (VTE) prevention in Japanese surgical patients with gynecologic malignancy.
  
  
  METHODS
  Patients ≥ 40 years old undergoing major surgery for gynecologic malignancy without preoperative VTE were included. Written informed consent was obtained. Enrolled patients received IPC immediately before surgery. After surgery, they were randomly assigned to either an enoxaparin group or an IPC-alone group. The enoxaparin group received enoxaparin injection (20 mg, subcutaneous, every 12 h) from postoperative day 2 to 8. IPC was discontinued after the first injection. In the IPC-alone group, IPC was continued until full ambulation. The primary end-point was incidence of VTE, including pulmonary embolism and deep vein thrombosis, regardless of symptoms. An interim analysis was to be conducted when the first 30 patients had completed the study protocol. A Data and Safety Monitoring Board was established for making recommendation on the continuation or termination of the study based on the interim results.
  
  
  RESULTS
  At the time of the interim analysis, six cases of VTE were found: five in the IPC-alone group and one in the enoxaparin group (Fisher's exact test, P = 0.08). Three patients in the IPC-alone group developed pulmonary embolism, but none in the enoxaparin group did so (Fisher's exact test, P = 0.10). The study was terminated following the Data and Safety Monitoring Board's recommendation.
  
  
  CONCLUSIONS
  Enoxaparin might have lowered the risk of VTE among surgical patients with gynecologic malignancy. Further studies are necessary to confirm this.
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.|Department of Education for Clinical Research, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Chie
authors.initials: C
authors.lastname: Nagata
authors.affiliation: Department of Obstetrics and Gynecology, Jikei University Kashiwa Hospital, Chiba, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tanabe
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takakura
authors.affiliation: Department of Obstetrics and Gynecology, Jikei University Kashiwa Hospital, Chiba, Japan.
authors.forename: Chikage
authors.initials: C
authors.lastname: Narui
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Motoaki
authors.initials: M
authors.lastname: Saito
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Nozomu
authors.initials: N
authors.lastname: Yanaihara
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Aikou
authors.initials: A
authors.lastname: Okamoto
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D005833:Genital Neoplasms, Female / Q000601:surgery*; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin
keywords: enoxaparin; gynecologic malignancy; intermittent pneumatic compression; surgical complication; venous thromboembolism