Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:August 2014
End Date:August 2015
Contact:David A Greuner, MD
Email:dgreuner@nycsurgical.net
Phone:888-286-6600

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In this proposal, the investigators seek to determine whether a reduced compression after
endovenous ablation procedure in treating superficial venous insufficiency affects the
outcomes. This study involves only the use of the compression stocking post endovenous
ablation procedure and everything else is standard according to current guidelines.

The investigators general strategy will be to determine the role of a minimal post-operative
compression and the status of patient satisfaction including (1) Success closure rate of the
treated vein. (2) Less pain; (3) Easier accepted by the patients.

All adults with varicose vein who are here in the investigators clinic to seek for
endovenous ablation treatments will be invited to participate in this study. The
participation in this research is entirely voluntary.

A. Each patient is given a code number instead of ID(identification) in the chart. Eligible
patients according to their vein size are divided into following groups using a
computer-generated randomization list:

1. Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;

2. Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;

3. Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;

4. Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.

B. Researchers: Data collectors and ultrasound technicians are blinded to the type of
intervention, using code instead of patient's ID. The operating surgeon will not be the one
who collects data. Performing physicians master these endovenous procedure techniques
equally, have performed a minimum of 20 procedures independently.

C. Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington,
DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2,
San Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein
System. Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are
standard care under current guideline.

D. The research takes place over 12 months in total. During that time, it will be necessary
for each patient to come to the clinic 6 times, for 1 hour each. The investigators would
like to meet with every patient 1 week and 1, 3, 6, 12 months after the procedure
respectively for a check-up.

Inclusion Criteria:

1. Aged 18 and older

2. Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of
leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins,
lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound)
correlates with vein diameter >5.5mm and reflex (>0.5 sec) in the upright position
identified with duplex ultrasound

3. Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic)
3 or higher

4. Fail to a minimum of three months of nonoperative management (leg elevation,
avoidance of prolonged standing, weight reduction, daily exercise for 30 min,
prescription strength gradient compression garments, NSAIDs antiinflammatory drug>)

5. Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small
saphenous vein (SSV).

Exclusion Criteria:

1. Documented allergy or intolerance to compression hosiery

2. Treated vein greater than 8.5 in diameters.

3. Previous history of DVT(deep venous thrombosis); Known prothrombotic state.

4. Arterial insufficiency as determined by ABI(ankle-brachial index)<0.5.

5. Obesity (BMI >35, class II).
We found this trial at
1
site
West Caldwell, New Jersey 07006
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from
West Caldwell, NJ
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