Tamotsu Obitsu1, Naoki Tanaka2, Atsushi Oyama3, Tatsuya Ueno4, Masaaki Saito1, Takuhiro Yamaguchi5, Airi Takagi6, Toshiki Rikiyama1, Michiaki Unno2, Takeshi Naitoh7. 1. Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan. 2. Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan. 3. Department of Surgery, Sendai City Medical Center, Sendai, Japan. 4. Department of Surgery, South Miyagi Medical Center, Shibata-gun, Japan. 5. Division of Biostatistics Tohoku University Graduate School of Medicine, Sendai, Japan; Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan. 6. Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan. 7. Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: naitot@med.kitasato-u.ac.jp.
Abstract
BACKGROUND: The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; therefore, standard prevention protocols have not been established, especially for minimally invasive procedures. We aimed to investigate the additional effect of low molecular weight heparin (LMWH) on prevention of VTE after laparoscopic surgery for gastrointestinal malignancy. STUDY DESIGN:From February 2013 to January 2017, 400 patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients), in which enoxaparin sodium (20 mg [= 2000 IU] twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced CT or ultrasonography when symptomatic or D-dimer was ≥10 μg/mL. RESULTS:VTE was observed in 1.2% and 4.0% of patients in the LMWH and Control groups, respectively (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR 1.02, 95% CI 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR 0.21, 95% CI 0.03-0.99), male sex (OR 0.12, 95% CI 0.01-0.60), and early cancer (OR 0.17, 95% CI 0.02-0.82) reduced the risk of VTE. CONCLUSIONS: Postoperative LMWH administration is safe. The additional effect of LMWH administration on the physical therapy was not statistically proven in this study. However, it could be useful for the patients with risk factors such as female sex, long operation time, and higher cancer stage.
RCT Entities:
BACKGROUND: The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; therefore, standard prevention protocols have not been established, especially for minimally invasive procedures. We aimed to investigate the additional effect of low molecular weight heparin (LMWH) on prevention of VTE after laparoscopic surgery for gastrointestinal malignancy. STUDY DESIGN: From February 2013 to January 2017, 400 patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients), in which enoxaparin sodium (20 mg [= 2000 IU] twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced CT or ultrasonography when symptomatic or D-dimer was ≥10 μg/mL. RESULTS:VTE was observed in 1.2% and 4.0% of patients in the LMWH and Control groups, respectively (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR 1.02, 95% CI 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR 0.21, 95% CI 0.03-0.99), male sex (OR 0.12, 95% CI 0.01-0.60), and early cancer (OR 0.17, 95% CI 0.02-0.82) reduced the risk of VTE. CONCLUSIONS: Postoperative LMWH administration is safe. The additional effect of LMWH administration on the physical therapy was not statistically proven in this study. However, it could be useful for the patients with risk factors such as female sex, long operation time, and higher cancer stage.
Authors: Stavros Kakkos; George Kirkilesis; Joseph A Caprini; George Geroulakos; Andrew Nicolaides; Gerard Stansby; Daniel J Reddy Journal: Cochrane Database Syst Rev Date: 2022-01-28
Authors: Dominique Farge; Corinne Frere; Jean M Connors; Alok A Khorana; Ajay Kakkar; Cihan Ay; Andres Muñoz; Benjamin Brenner; Pedro H Prata; Dialina Brilhante; Darko Antic; Patricia Casais; María Cecilia Guillermo Esposito; Takayuki Ikezoe; Syed A Abutalib; Luis A Meillon-García; Henri Bounameaux; Ingrid Pabinger; James Douketis Journal: Lancet Oncol Date: 2022-07 Impact factor: 54.433