Меню
Набор скоро начнётся NCT07445425

Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins

Без фазы С лечением Varicose Veins of Lower Limb

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Staged surgery group, Concomitant surgery group.
Кому может быть актуально
Состояния в реестре: Varicose Veins of Lower Limb. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study

Обзор

The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are: Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies? Participants will: Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination. Record their symptoms

Вмешательства

  • Процедура Staged surgery group
    The patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequenc
  • Процедура Concomitant surgery group
    While the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal.

Первичные конечные точки

  • The re-intervention rate [Срок оценки: 1 week, 3 months and 6 months after surgery]
Вторичные конечные точки (12)
  • Treatment cost [Срок оценки: 6 months after surgery]
  • Success rate of varicose vein closure [Срок оценки: 1 week, 3 months and 6 months after surgery]
  • Operation time [Срок оценки: During the operation]
  • Number of incisions [Срок оценки: During the operation]
  • Tumescent anesthesia solution dosage [Срок оценки: During the operation]
  • The amount of intraoperative bleeding [Срок оценки: During the operation]
  • AVVQ score [Срок оценки: Before surgery, 1 week, 3 months and 6 months after surgery]
  • VAS score [Срок оценки: Before surgery, 1 week, 3 months and 6 months after surgery]
  • VCSS score [Срок оценки: Before surgery, 1 week, 3 months and 6 months after surgery]
  • Postoperative complications [Срок оценки: 1 week, 3 months and 6 months after surgery]
  • Time to return to regular work [Срок оценки: 1 week after surgery]
  • Patient satisfaction [Срок оценки: During the operation and 6 months after surgery]

Критерии участия

Критерии включения

aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.

Критерии исключения

Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 21 центр
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Peking University International Hospital — Пекин
  • Peking University Third Hospital — Пекин
  • Guangxi Zhuang Autonomous Region People's Hospital — Nanning
  • The First Affiliated Hospital of Guangxi University of Chinese Medicine — Nanning
  • Hainan Provincial Hospital of Traditional Chinese Medicine — Haikou
  • Zhengzhou Central Hospital — Чжэнчжоу
  • Zhoukou Central Hospital — Zhoukou
  • … и ещё 13 центров

Идентификаторы

NCT: NCT07445425 · 2025-2700-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗