跳至主要内容
临床试验/CTRI/2025/02/080433
CTRI/2025/02/080433招募中不适用

Subcutaneous Endoscopic Varicose Vein Surgery Laparoscopic innovation in surgical management of varicose veins

All India Institute of Medical Sciences Bhubaneswar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the safety and feasibility of SEVVS

研究概览

简要总结

Varicose vein is a disorder characterised by elongated, dilated and tortuous veins primarily affecting the lower extremities. This condition typically involves malfunctional venous valves which results in pooling of blood in lower extremities and venous insufficiency. Venous hypertension not only causes cosmetic concerns but can also lead to discomfort, pain and complications such as skin discoloration, venous ulcers, bleeding and thrombophlebitis. Over the years, an array of treatment modalities has been developed, encompassing a spectrum from conservative management strategies to more invasive surgical approaches and endovenous interventions. Open surgical approaches involving saphenofemoral junction (SFJ) ligation, vein stripping and ambulatory phlebectomy are frequently associated with postoperative sequelae such as pain, discomfort, wound infections and paraesthesia Endovenous procedures (RFA, EVLA, EVTA etc) are globally acknowledged as primary treatment modalities for managing varicose veins or addressing clinical manifestation of venous pathology. Nevertheless, a significant constraint of these interventions lies in their applicability in highly tortuous veins, requisite availability of specialised equipment, necessary expertise and associated cost. While subfascial endoscopic perforator surgery (SEPS) has an established role in laparoscopic management of incompetent perforators, there is presently no laparoscopic technique articulated for simultaneous treatment of saphenofemoral junction (SFJ) incompetence and perforator incompetence in a single operative session. We propose a fully laparoscopic approach for comprehensive management of varicose veins encompassing both precise identification and targeted treatment of venous incompetence, thereby optimizing patient outcome.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients with varicose vein of lower limb planned for surgery.

排除标准

  • Patients with contraindication to spinal/general anasthesia
  • Refusal to participate in the study.

结局指标

主要结局

To evaluate the safety and feasibility of SEVVS

时间窗: Safety - upto 30 days | Feasibility - During surgery(2-3 hours)

次要结局

  • complications(30 days)
  • Quality of life(six month)
  • Recurrences(Six months)

研究者

发起方
All India Institute of Medical Sciences Bhubaneswar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pankaj Kumar

All India Institute of Medical Sciences,Bhubaneswar

研究点 (1)

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