跳至主要内容
临床试验/NCT05625074
NCT05625074招募中不适用

The Portuguese National Health Service Reality in Varicose Vein Surgery - a Transversal Study on the Early Postoperative of Superficial Venous Surgery.

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年11月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

João Rocha Neves

Principal Investigator

Universidade do Porto

研究点 (1)

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National Varicose Vein Study - Portugal | 临床试验