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

Vedovati 2014.

Methods RCT, assessor‐blinded, compression ultrasonography.
Participants Patients undergoing elective laparoscopic surgery for colorectal cancer.
Interventions LMWH (enoxaparin 4000 IU in 79% allocated to extended prophylaxis, dalteparin 5000 IU in 21% allocated to extended prophylaxis, total treatment period 27 to 31 days).
Outcomes LMWH 112
Control 113
Notes LMWH prophylaxis medication varied prior to randomization to extended duration LMWH prophylaxis (enoxaparin 4000 UI or dalterparin 5000 UI or nadroparin 2850 IU). The study was interrupted after the results of the interim analysis showed a reduction in the rate of VTE in patients assigned to extended prophylaxis (P < 0.01).
Compression ultrasonography day 26 to 30.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Centralized randomization, method not stated in manuscript.
Allocation concealment (selection bias) Unclear risk Unclear.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Compression ultrasonography evaluated by blinded investigator. Unclear if data‐analysts blinded.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Patients and presumably caregivers not blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Terminated prematurely after interim analysis showed a reduction in the rate of VTE in patients assigned to extended prophylaxis.
Selective reporting (reporting bias) Low risk Intention‐to‐treat analysis on all patients with at least 26 days of follow up and at least one dose of medication; it appears all randomized patients met these parameters.
Other bias Low risk The study appears to be free of other sources of bias.

IPC: intermittent pneumatic compression; IU: international units: LMWH: low molecular weight heparin; RCT: randomized controlled trial; VTE: venous thromboembolism.