Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Occlusions Vein
- Sponsor
- Kyung Hee University Hospital at Gangdong
- Enrollment
- 146
- Locations
- 2
- Primary Endpoint
- Closure rate of the target vein/ Absence of refluxing vein
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
Detailed Description
Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.
Investigators
Jin Hyun Joh
Associate professor
Kyung Hee University Hospital at Gangdong
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 80 years of age at the time of enrollment
- •Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
- •Diameter of saphenous vein between 2mm to 20mm (with standing position)
- •One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
- •Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5
Exclusion Criteria
- •Previous treatment in targeted vein segment
- •Tortuous vein in which the delivery catheter cannot be inserted
- •Aneurysm of target vein segment \>20 mm
- •Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
- •Known hypercoagulable disorder
- •Active malignancy
- •Regular use of systemic anticoagulation
- •Current use of systemic anticoagulant
- •Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
- •Unable to comply with the schedule and protocol evaluations
Outcomes
Primary Outcomes
Closure rate of the target vein/ Absence of refluxing vein
Time Frame: 3 months
The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator.
Secondary Outcomes
- Satisfaction of the patients: satisfaction rate(1, 3, 6, 12 and 24 months after treatment)
- Ecchymosis(3 days)
- Acceptability of Quality of life score(1, 3, 6, 12 and 24 months after treatment)
- Perioperative pain with visual analog scale(3 days)
- Venous Clinical Severity Score(1, 3, 6, 12 and 24 months after treatment)