Endovenous Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Lower Limb Varicose Veins.
Xiaoyu Yang, Jihua Li, Xiao Bai...
https://pubmed.ncbi.nlm.nih.gov/37423329Actively Recruiting
Age: 18Years - 90Years
All Genders
ID06693245
Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation and Analysis of Related Factors
Led by Chengdu University of Traditional Chinese Medicine · Updated on 2024-11-18
155
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pain experienced during microwave ablation treatment for great saphenous vein varicosities, a type of varicose vein in the lower limbs. This observational study aims to analyze pain scores at various points during surgery and explore factors such as age, gender, body mass index, and the amount of swelling fluid used. The goal is to better understand and improve surgical techniques to reduce pain and enhance patient experience. The study involves measuring the great saphenous vein diameter before surgery using ultrasound and CEAP classification. Patients undergo endovenous microwave ablation combined with foam sclerotherapy and point stripping treatment. During surgery, researchers record pain scores at puncture and catheter insertion, swelling fluid injection, microwave generator operation, and surgery end. They also document factors like operating room temperature and tumescent fluid volume. The relationship between these factors and pain levels is analyzed to identify ways to manage pain better. Participants will have their pain assessed using the Visual Analogue Scale during surgery. Data related to surgery, including procedural details and pain scores, are collected throughout the operation. This study focuses on intraoperative pain and its correlation with treatment variables. The involvement includes preoperative examinations, intraoperative monitoring, and pain scoring. The study is expected to help improve anesthesia techniques and patient comfort during varicose vein treatments.
CONDITIONS
Brief Title
Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years old
- Life expectancy greater than 12 months
- Clinical diagnosis of primary varicose veins, CEAP classification C2-C6, with symptoms such as pain, burning, heaviness, fatigue, itchy skin, or night cramps
- Doppler ultrasound confirming great saphenous vein diameter between 3mm and 12mm when standing
- Doppler ultrasound confirming the vein is in the saphenofascia or more than 1 cm below the skin surface
- Endovenous microwave ablation treatment planned only for unilateral great saphenous vein
- Willingness to cooperate and complete all study examinations as specified in the protocol
You will not qualify if you...
- Presence of great saphenous vein thrombosis or deep vein thrombosis, or history of deep vein thrombosis and pulmonary embolism
- Recurrence after prior varicose vein surgery (C2r)
- Severely distorted great saphenous vein trunk preventing catheter passage
- Severe lower limb ischemia with ankle brachial pressure index less than 0.8
- Known allergy to study drugs or device materials
- Previous pacemaker or defibrillator implantation and current anticoagulation therapy
- Pregnant or lactating women
- Unable or unwilling to participate in the study
- Participation in other drug or device research
- Skin malignancies other than treated non-melanoma
- Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs for venous disease pain
- Investigator judgment that endovenous treatment is unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo ultrasound and clinical assessments to measure the diameter of the great saphenous vein and confirm eligibility for treatment.
1 visit (in-person)
Observation
Duration - Day of surgery
Participants receive endovenous microwave ablation treatment for varicose veins with pain and procedural data collected during surgery.
1 surgical visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610000
Actively Recruiting
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Research Team
C
Chunshui He, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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