Rao 2005.
Study characteristics | ||
Methods |
Study design: double‐blind prospective comparative trial Method of randomisation: not mentioned Blinding: participants ‐ yes, doctor ‐ yes, outcome assessors ‐ yes Power calculation: not mentioned Total number of participants: 20 Total number of procedure: 40 Treatment localisation: leg veins Number of exclusions post‐randomisation: none Number of withdrawals and reasons: none |
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Participants |
Setting: outpatient site Country: USA Gender: 19 women, 1 man Age: not mentioned Inclusion criteria: varicose, reticular or telangiectatic leg veins or both, without incompetence at the saphenofemoral or saphenopopliteal junctions Exclusion criteria: each person’s leg veins were evaluated for extent, quality, and size and were placed into one of the following study categories: veins < 1 mm in diameter, veins 1 to 3 mm in diameter, and veins 3 to 6 mm in diameter |
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Interventions |
Treatment 1: STS Treatment 2: POL Sclerotherapy was performed by standard technique on only 1 leg in a single treatment session, always by the same physician for a given participant Duration of follow‐up: 12 weeks Use of compression: compression stocking |
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Outcomes | 4 independent physicians, who were blinded to the sclerosing agents administered, assessed these images (photographs) for overall clearance of vessels based on vessel size. Participants completed questionnaires to assess the tolerability and satisfaction of treatment with each sclerosing agent | |
Funding sources | No details provided | |
Declarations of interest | No details provided | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The treating physician was blinded to the agent being injected |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 4 independent physicians blinded assessed the photographs for overall clearance of vessels |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 20 participants completed the study |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |