Belcaro 1999.
Methods | Multicentre, open RCT; 6‐month follow‐up. | |
Participants | 562 non‐hospitalised participants with ST, large varicose veins, and venous incompetence; 181 males, 263 females; mean age range across study groups 53‐56 years. Diagnosis of ST objectively confirmed by colour Doppler compression ultrasonography. | |
Interventions | Surgery (ligation). Surgery (complete stripping). Low‐dose sc heparin. LMWH. Coumadin. |
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Outcomes | DVT and extension of ST after treatment and after 3 and 6 months. Not specified if DVT and extension of ST were symptomatic or asymptomatic. | |
Notes | All participants received compression bandages. Duration of non‐surgical treatments unclear and dose of heparin or coumadin not specified. Funding: not reported. Disclosure of potential COI: not reported, no COI forms available. Gianni Belcaro erased from the UK medical register in June 2007 for "misconduct," which seems to have been that he included as coauthors on his papers people who were not involved in the research. The General Medical Council report did not suggest that data were falsified webcache.gmc‐uk.org/minutesfiles/3313.HTML. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) All outcomes | High risk | No information provided about blinding, but it was likely an open study. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 118 (21%) participants lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported. |