Skip to main content
. 2019 Aug 26;2019(8):CD004318. doi: 10.1002/14651858.CD004318.pub5

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.
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.