ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications.
Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols.
There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.
排除标准
- •Patients who are minors (< 18 years old) or adults who have not given their consent to participate in the study.
- •Presence of severe obliterating arterial disease of the lower limbs (ABI <0.5)
- •Obesity (BMI >30)
- •Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:
- •lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).
- •Pregnancy.
研究组 & 干预措施
K1, 18-21 mmHg
Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation
干预措施: Elastic-compressive stockings (Device)
K2, 23-32 mmHg
Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation
干预措施: Elastic-compressive stockings (Device)
结局指标
主要结局
Postoperative Pain
时间窗: 7 days after surgery
Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)
次要结局
- Analgesic Drugs Use(30 days from intervention)
- Lower limb edema(30 days from intervention)
- Postoperative Complications(30 days from intervention)
- Discomfort(30 days from intervention)
- Evaluation of Quality of Life(30 days from intervention)
研究者
Daniela Mazzaccaro
Medical Doctor and Researcher
IRCCS Policlinico S. Donato