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 |
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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. |