Bergqvist 2002.
Methods | RCT, double‐blinded, venography | |
Participants | Patients undergoing elective, open, curative surgery for malignant disease of the gastrointestinal (excluding esophagus) tract, genitourinary tract or female reproductive organs. | |
Interventions | LMWH (enoxaparin 40 mg, total treatment period of 25 to 31 days) or placebo. | |
Outcomes | LMWH 165 Placebo167 | |
Notes | ENOXACAN II trial. Follow‐up period 3 months. Complete follow‐up. All patients were scheduled for bilateral venography. Adequate definitions of VTE and bleeding complications were described in the paper. Venography performed between 25 and 31 days. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described in the manuscript. Randomization stratified according to the country where institution was located. |
Allocation concealment (selection bias) | Unclear risk | Not described in manuscript. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo‐controlled double‐blind study. Patients, healthcare providers, data collectors, outcome assessors, and data analysts were blinded. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described in manuscript. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Eighty‐one (32.7%) patients in placebo group and 88 (34.8%) patients in experimental group excluded due to lack of adequate venography. |
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 | Low risk | The study appears to be free of other sources of bias. |