Kern 2004.
Study characteristics | ||
Methods |
Study design: A single‐blind, randomised, comparative study Method of randomisation: this study was a randomised, single‐blinded trial. Area treated and type of veins: only the lateral face of the thigh was considered for the study. A single leg per person was treated. If both thighs were affected, only the left one was treated and evaluated for the study, as defined by the study protocol. Each participant was randomly assigned either to chromated glycerin, POL solution, or POL foam Blinding: participants were unaware of the choice of the sclerosing method. The treating physician (P.K.) was not blinded. A doubled‐blinded study is not realizable with the different sclerosing aware of the sclerosing agent used, because of the great difference in viscosity between glycerin and POL Power calculation: not mentioned Total number of participants: 150 Total number of procedures: 150 Treatment localisation: lateral face of the thigh Number of exclusions post‐randomisation: none Number of withdrawals and reasons: 3 lost to follow‐up |
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Participants |
Setting: outpatient site Country: Switzerland Gender: women Age: range 17 ‐ 80 years, mean: 46.5. Inclusion criteria: consecutive, informed, consenting women who were presenting with primary telangiectasias and reticular leg veins on the lateral face of the thigh (C1 A or S) Exclusion criteria: reflux in the deep veins, saphenous trunk, saphenous junctions or saphenous collateral, incompetent perforators, non‐compressible deep or superficial veins, recanalised thrombus, allergy against chrome or polidocanol, and previous sclerotherapy |
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Interventions |
Treatment 1: chromated glycerin Treatment 2: POL solution Treatment 3: POL foam Technique: 2 mL syringes were used for chromated glycerin and POL solution, whereas 2‐mL sterilised glass syringes were used for the foam technique. Injections were performed with a 30.5‐gauge needle. All treatments were performed with the participant in the supine position. Approximately 60 to 100 injections were performed during the session. Reticular feedings veins were injected before the telangiectasias. Participants remained supine for 5 minutes after the last injection before a compressive bandage was applied with either an elastic band or a graduated compressive stocking (26 ‐ 33 mm Hg), which was worn for 1 week during the day Number of sessions: A single sclerosing session was performed in each participant. Treatment sites were photographed immediately before and after the treatment in supine position. Immediately after the treatment, the participants were asked to assess the pain score on a visual scale Duration of follow up: 5 weeks Use of compression: graduated compressive stocking |
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Outcomes | Visual improvement: participants were questioned about their satisfaction using a visual scale ranging from negative results to great satisfaction. The physician had the possibility of assessing satisfaction on a scale from 0 to 100, with 100 representing the maximal satisfaction rate. A control photograph was performed at 5 weeks after treatment in similar conditions as those set for the pretreatment picture. Two independent experts who were not involved in the treatment phase and who were blinded to the sclerosant used were asked to analyse the photographs and to give an efficacy score or a vessel clearance score from 0 to 10 and to report side effects. To assess the intra‐observer reproducibility of photograph analysis, the expert, still blinded, made a second analysis of the same pictures 1 month later Side effects: the treating physician, not blinded to the agent, checked for immediate side effects or those reported by the participants. He also identified microthrombi, pigmentations or matting, which may be difficult to evaluate on the photographs | |
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 | States "randomised", no further details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The treating physician, not blinded to the agent |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Two independent experts who were not involved in the treatment phase and who were blinded to the sclerosant used were asked to analyse the photographs and to give an efficacy score or a vessel clearance score from 0 to 10 and to report side effects. Both experts are phlebologist physicians skilled with sclerotherapy. To assess the intraobserver reproducibility of photograph analysis, the expert, still blinded, made a second analysis of the same pictures 1 month later |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 3 participants lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |