Chronic Venous Insufficiency, Occlusions Vein
Conditions
Keywords
varicose vein, stripping, endovenous, ablation, Occlusion, quality of life
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.
Interventions
PROCEDURECyanoacrylate closure
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
PROCEDURESurgical stripping
All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.
Sponsors
Kyung Hee University Hospital at Gangdong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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 * Unable to ambulate * Currently pregnant or breast feeding * Known sensitivity to cyanoacrylate adhesives * Symptomatic peripheral arterial disease with ankle-brachial index \<0.9 * Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment * Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure rate of the target vein/ Absence of refluxing vein | 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
| Measure | Time frame | Description |
|---|---|---|
| Venous Clinical Severity Score | 1, 3, 6, 12 and 24 months after treatment | Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst)) |
| Perioperative pain with visual analog scale | 3 days | The subject will be asked to rate pain on a 0-10 numeric rating scale. (minimum-0 (best), maximum-10 (worst)) |
| Ecchymosis | 3 days | The investigator will score the subjects ipsilateral leg of the occurrence of ecchymosis along treated segment, rated on a 0- to 5-point graded scale (0, none; 1, involving \<25% of the treatment area; 2, 25%-50%; 3, 50%-75%; 4, 75%-100%; 5, extension above or below the treatment segment) |
| Acceptability of Quality of life score | 1, 3, 6, 12 and 24 months after treatment | The quality of life scores are measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQOL five dimensions questionnaire (EQ-5D). The AVVQs are scored using a questionnaire. The total score for the 13 questions ranges from 0 to 100 points, with 0 points indicating the best possible quality of life. The EuroQOL is an instrument which evaluates the generic quality of life. The EuroQOL descriptive system is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
| Satisfaction of the patients: satisfaction rate | 1, 3, 6, 12 and 24 months after treatment | The subject will be asked to the satisfaction rate by five response categories (strongly agree, agree, uncertain, disagree, strongly disagree) after asking as following: I'm very satisfied with the medical care I receive. |
Countries
South Korea
Contacts
Primary ContactJin Hyun Joh, MD, PhD
Outcome results
None listed