The Portuguese National Health Service Reality in Varicose Vein Surgery - a Transversal Study on the Early Postoperative of Superficial Venous Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Antibiotic prophylaxis regimens
研究概览
简要总结
The National Varicose Vein Study is a cross-sectional, multicenter, observational study. The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.
详细描述
Chronic venous disease is one of the most prevalent pathologies in the world population. It presents a spectrum of variable manifestations, culminating in the most severe form, active venous ulcer. The clinical evaluation, the study of venous anatomy by echo- Doppler and the indications for surgical treatment are standardized in guidelines. The same applies to the techniques for surgical treatment that, in the long term, present equally satisfactory results. Thus, currently, in the Portuguese national health system, the surgical technique most frequently used is conventional surgery. As for postoperative care, namely thromboprophylaxis regimens, analgesia regimens, there is greater variability in its application between clinics and institutions, which may result in significant differences in postoperative recovery. In this way, we intend to develop an observational, cross-sectional and multicenter study, comparing postoperative care protocols and patient compliance and impact on quality of life, as well as absence from work.
The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at CHUP, CHUSJ and CHUC
- •Male and female;
- •Age over 18 years;
- •All clinical presentations (C) included in the CEAP classification system;
- •Period from November 2022 onwards;
- •Conventional surgical treatment of at least one great saphenous vein;
- •Patients treated using the following techniques: arch ligation +/- trunk stripping.
排除标准
- •Exclusive or concomitant treatment with endovenous surgery (thermal ablation by laser or radiofrequency...);
- •Treatment by conservative conventional surgery of the great saphenous vein (CHIVA, ASVAL);
- •Varicose surgery not involving the great saphenous vein;
- •Age under 18 years;
- •Patients treated in hospital units not covered by the study.
结局指标
主要结局
Antibiotic prophylaxis regimens
时间窗: In the postoperative period between 25 to 45 days
Duration of the regimen. Beta lactamic vs remaining antibiotics
Impact on quality of Life;
时间窗: In the postoperative period between 25 to 45 days
rVCSS - revised venous clinical seveity score
Compliance with drug therapy;
时间窗: In the postoperative period between 25 and 45 days
How many days were recomended to take the drug; How many days the patient took the drug
Complications and extraordinary recourse to health care
时间窗: In the postoperative period between 25 and 45 days
Observation in the outpatient clinic and urgency department
Pharmacological and/or mechanical thromboprophylaxis
时间窗: In the postoperative period between 25 and 45 days
Regimen (low molecular weight Heparin vs direct oral anticoagulant; elastic stockings). duration of the thromboprophilaxis regimen
次要结局
- Period of work disability(In the postoperative period between 25 and 45 days)
研究者
João Rocha Neves
Principal Investigator
Universidade do Porto
