Comparative study of the safety and efficacy of perforator ligation vs foam sclerotherapy for below knee perforators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ
研究概览
简要总结
Below-knee varicosities, commonly due to incompetent perforator veins, contribute significantly to symptoms, skin changes, and long-term disability. There is a need to determine whether surgical or sclerotherapy-based approaches offer better clinical outcomes, safety, and patient satisfaction. Although perforator ligation and foam sclerotherapy are commonly used to treat varicose veins, there is no clear consensus in the literature about which treatment method offers better clinical outcomes. There are variations in success rates, complication profiles and patient satisfaction between the two procedures. A well-structured study is needed to provide robust, comparative evidence to guide clinical decision-making.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 and above 2.Diagnosed with symptomatic varicose veins with incompetent perforators confirmed by Doppler ultrasound 3.Undergoing perforator ligation or foam sclerotherapy for below knee perforators, irrespective of the simultaneous appropriate above-knee treatment (Trendelenberg’s procedure/RFA/EVLA).
排除标准
- •1.Pregnant or breastfeeding women 2.Patients with active deep vein thrombosis (DVT).
结局指标
主要结局
To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ
时间窗: To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ | 14 questionnaire at baseline(pre-operatively in person) and at 3 months post-op(via telephonic interview).
14 questionnaire
时间窗: To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ | 14 questionnaire at baseline(pre-operatively in person) and at 3 months post-op(via telephonic interview).
次要结局
- To compare the incidence of post-operative complications between the two treatment groups
- To assess and compare the post-operative pain in both treatment groups using VAS scale(pain evaluation using VAS scale on POD-0 and POD-1)
- To compare the time to return to normal daily activities in each treatment group(to be asked to the patients via telephonic interview at 3 months.)
研究者
Dr Kumar Shivam
Kasturba Medical College, Manipal