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. 2019 Aug 26;2019(8):CD004318. doi: 10.1002/14651858.CD004318.pub5

Sakon 2010.

Methods RCT, assessor interpretation of venography or ultrasonography not described.
Participants Patients undergoing elective, curative laparotomy for cancer of > 45 minutes duration with a life expectancy of > 6 months after surgery.
Interventions LMWH (enoxaparin 20 mg twice daily for 14 days) or no treatment.
Outcomes LMWH/IPC = 113
IPC = 38
Notes The study used patients receiving mechanical prophylaxis (IPC) as a reference group for VTE incidence during the study period, but was not intended to be compared statistically with the enoxaparin group. In the total treated population, (n = 109) LMWH mean treatment duration was 10.5 +/‐ 3.3 days, and in the modified‐intention‐to‐treat population (n = 83), LMWH mean treatment duration was 11 +/‐ 2.8 days. The defined follow‐up period was 14 days following venography (day 28 +/‐ 5). All patients were scheduled for bilateral venography on day 14 after surgery. Adequate definitions of VTE and bleeding complications were described in the paper.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomized in a 3:1 ratio (LMWH to IPC), method not stated in the manuscript.
Allocation concealment (selection bias) Unclear risk Not described in the manuscript.
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label study, no stated blinding of VTE objective end points or primary safety end point (bleeding).
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 26 patients (23.9%) in LMWH group and 7 patients (18.4%) in IPC group excluded from total treated population due to inadequate VTE assessment or measurement.
Selective reporting (reporting bias) Unclear risk Modified intention‐to‐treat analysis of patients reaching an evaluable VTE end point (venogram or objection verification of symptomatic VTE).
Other bias High risk Study and editorial support financially supported by Sanofi‐Aventis K.K., Japan. The principle investigator (MS) reported conflict of interest with Sanofi‐Aventis (Japan), GlaxoSmithKline (Japan), Astellas, and Bayer pharmaceutical companies.