Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 主要终点
- Freedom from reflux
研究概览
简要总结
Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.
详细描述
During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.
Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.
The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.
During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.
At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical classification of venous disease C2-C4
- •ultrasound-verified reflux in the GSV
- •mean GSV diameter in the thigh between 5 and 12 millimetres
- •informed consent.
排除标准
- •body mass index (BMI) of over 40
- •peripheral arterial disease
- •lymphoedema
- •pregnancy
- •allergy to either the sclerosant or lidocaine
- •severe general illness
- •malignancy
- •previous deep venous thrombosis
- •previous varicose vein intervention in the same leg
- •coagulation disorders
结局指标
主要结局
Freedom from reflux
时间窗: five years after the treatment
The absence of reflux in the treated great saphenous vein
Disease-specific quality of life
时间窗: five years after the treatment
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Occlusion rate
时间窗: five years after the treatment
Occlusion rate of the great saphenous vein
次要结局
- Peroperative and immediate postoperative pain(During the procedure, immediately after, and at one week after the treatment)
- Sick leave(During the immediate postoperative period up to one month)
- Complications(Up to five years after the treatment)
- Pain medication(During the immediate postoperative period up to one month)
- 30-day occlusion rate(30 days after the treatment)
研究者
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital