Kakkar 2010.
Methods | RCT, double‐blinded, placebo‐controlled, venography. | |
Participants | Patients undergoing elective, open, curative or palliative surgery for malignant disease of the gastrointestinal (excluding esophagus) tract, genitourinary tract or female reproductive organs. | |
Interventions | LMWH (bemiparin 3500 IU, total treatment period of 24 to 32 days), or placebo. | |
Outcomes | LMWH 248 Placebo 240 |
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Notes | CANBESURE trial. Follow‐up 74 to 90 days after randomization. Follow‐up complete. All patients were scheduled for bilateral venography. Adequate definitions of VTE and bleeding complications were described in the paper. Venography performed on day 18 to 22, two days before the last LMWH injection. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation. |
Allocation concealment (selection bias) | Unclear risk | Not described in the manuscript. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled. All deaths and symptomatic VTE events centrally evaluated by independent blinded committee. Venograms blinded and centrally evaluated by independent committee. Bleeding events adjudicated by an independent data safety monitoring board. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo injection 0.9% sodium chloride, 0.2 mL. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Sixty‐seven (21.3%) patients in experimental group, 70 (22.6%) patients excluded due to inadequate venography. |
Selective reporting (reporting bias) | Unclear risk | Modified intention‐to‐treat population, included all randomized patients who received at least one dose of randomized treatment and had an assessable venogram, or documented symptomatic VTE, or died during the double‐blind period. |
Other bias | Low risk | The study appears to be free of other sources of bias. |