Intermittent pneumatic compression versus additional prophylaxis with enoxaparin for prevention of venous thromboembolism after laparoscopic surgery for gastric and colorectal malignancies : multicentre randomized clinical trial

Autor: R. Yokota, Hideki Kawamura, Shigenori Homma, Yosuke Ohno, Nobuki Ichikawa, Y. Maeda, Toraji Amano, Tadashi Yoshida, N Takahashi, Akinobu Taketomi, T. Funakoshi, Hirofumi Kamachi
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Laparoscopic surgery
medicine.medical_specialty
medicine.drug_class
medicine.medical_treatment
Deep vein
lcsh:Surgery
Intermittent pneumatic compression
Hemorrhage
030230 surgery
03 medical and health sciences
Postoperative Complications
0302 clinical medicine
Stomach Neoplasms
Vascular
parasitic diseases
medicine
Upper GI
Humans
cardiovascular diseases
Enoxaparin
Intermittent Pneumatic Compression Devices
Aged
Performance status
business.industry
Anticoagulant
Anticoagulants
Venous Thromboembolism
lcsh:RD1-811
General Medicine
Middle Aged
medicine.disease
Surgery
Pulmonary embolism
Randomized Clinical Trials
medicine.anatomical_structure
030220 oncology & carcinogenesis
Randomized Clinical Trial
Chemoprophylaxis
Lower GI
Female
Laparoscopy
Colorectal Neoplasms
Pulmonary Embolism
business
Fibrinolytic agent
Zdroj: BJS Open, Vol 4, Iss 5, Pp 804-810 (2020)
BJS Open
ISSN: 2474-9842
Popis: Background The role of antithrombotic chemoprophylaxis in prevention of venous thromboembolism (VTE) in laparoscopic surgery for gastric and colorectal malignancies is unknown. This study compared the addition of enoxaparin following intermittent pneumatic compression (IPC) with IPC alone in patients undergoing laparoscopic surgery for gastrointestinal malignancy. Methods In this multicentre RCT, eligible patients were older than 40 years and had a WHO performance status of 0 or 1. Exclusion criteria were prescription of antiplatelet or anticoagulant drugs and history of VTE. Patients were allocated to IPC or to ICP with enoxaparin in a 1 : 1 ratio. Stratification factors included sex, location of cancer, age 61 years and over, and institution. Enoxaparin was administered on days 1–7 after surgery. Primary outcome was VTE, evaluated by multidetector CT on day 7. Results Of 448 patients randomized, 208 in the IPC group and 182 in the IPC with enoxaparin group were evaluated. VTE occurred in ten patients (4·8 per cent) in the IPC group and six (3·3 per cent) in the IPC with enoxaparin group (P = 0·453). Proximal deep vein thrombosis and/or pulmonary embolism occurred in seven patients (3·4 per cent) in the IPC group and one patient (0·5 per cent) in the IPC with enoxaparin group (P = 0·050). All VTE events were asymptomatic and non‐fatal. Bleeding occurred in 11 of 202 patients in the IPC with enoxaparin group, and one patient needed a transfusion. All bleeding events were managed by discontinuation of the drug. Conclusion IPC with enoxaparin after laparoscopic surgery for gastric and colorectal malignancies did not reduce the rate of VTE. Registration number: UMIN000011667 ( https://www.umin.ac.jp/).
This RCT compared intermittent pneumatic compression (IPC) alone with IPC plus enoxaparin for 1 week after surgery in the prevention of venous thromboembolism (VTE) in patients undergoing laparoscopic surgery for gastric or colorectal malignancy. Although VTE occurred in 4·8 per cent of the ICP‐alone group and 3·3 per cent of the ICP with enoxaparin group (P = 0·453), the occurrence of proximal deep vein thrombosis and/or pulmonary embolism was reduced from 3·4 to 0·5 per cent by the addition of enoxaparin (P = 0·050). No additional value of enoxaparin in patients who recover uneventful
Databáze: OpenAIRE
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