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临床试验/NCT05707169
NCT05707169进行中(未招募)不适用

Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Long Saphenous Vein Incompetence: Evaluating the Kissing Technique

Mansoura University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
800
试验地点
1
主要终点
Recurrence

研究概览

简要总结

EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT).

In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV.

详细描述

INTRODUCTION Chronic venous disease (CVD) is one of the most common pathologies in the general population of adults in both industrialized and developing countries. the most severe form of CVD is venous ulceration with an overall prevalence of about 1 % in the adult population, which increases with age and is more common in women and obese patients. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems. Varicose veins (VVs) is a common disease in adults, and VVs without skin changes are present in about 20% of the population, while active ulcers are found in 0.5%.The traditional surgical treatment of VVs is high ligation of the great saphenous vein (GSV), axial stripping and phlebotomy, but the postoperative clinical recurrence is as high as 60%.4 Minimally invasive techniques, such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), have become widely used for the treatment of VVS. Several reports have shown Several reports have shown that endovenous techniques are as effective as traditional procedures.

EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT).

In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV. Postoperative quality of life (QoL) analysis was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS).

Aim of the work: To compare laser therapy ablation of long saphenous vein reflux by conventional and the kissing techniques on development of DVT, recurrence rate of VVs, ulcer-free time, and health-related quality of life.

Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura University, Faculty of Medicine, Mansoura, Egypt .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary symptomatic VVS (CEAP, C3-C6), sapheno-femoral junction (SFJ) incompetence, and GSV reflux from the groin to below the knee

排除标准

  • history of venous surgery, suspected or proven deep venous thrombosis, history of DVT, reflux of deep veins to distal limb, duplication of GSV, and patients' refusal to participate in the trial.

研究组 & 干预措施

Two Centimeters from Saphenofemoral Junction

Experimental

Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture. Using 1470 nm laser and a radial fibre for less discomfort. The catheter is placed 2-2.5 cm distal to the sapheno-femoral junction. Tumescence with a mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

干预措施: Saphenous Ablation (Procedure)

Two Centimeters from Saphenofemoral Junction

Experimental

Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture. Using 1470 nm laser and a radial fibre for less discomfort. The catheter is placed 2-2.5 cm distal to the sapheno-femoral junction. Tumescence with a mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

干预措施: Endogenous Laser Ablation (EVLA) (Device)

Zero point Ablation

Experimental

The catheter is positioned exactly at the terminal valve of the SFJ (kissing the valve).

干预措施: Saphenous Ablation (Procedure)

Zero point Ablation

Experimental

The catheter is positioned exactly at the terminal valve of the SFJ (kissing the valve).

干预措施: Endogenous Laser Ablation (EVLA) (Device)

结局指标

主要结局

Recurrence

时间窗: 6 months

both duplex ultrasound and the clinical examination. A varicose vein that had not been observed before or previously been marked by the patient on the AVVQ form was considered to be a recurrent varicose vein (owing to neo-vascularization or dilation of pre-existing veins).

次要结局

  • Heat induced thrombosis(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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