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

NCT02241707 | Withdrawn

• 1 other identifier: NYCSA-2014-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Vein; Venous Insufficiency

Keywords

Varicose vein; Endovenous ablation; Compression

Outcome Measures

Primary Outcomes (1)

• Vein closure success rate.

  Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.

  up to 12 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults, both male/female, with varicose vein who are here in our clinic to seek for endovenous ablation treatments will be invited to participate in this study.

You may qualify if:

• Aged 18 and older
• 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
• Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3 or higher
• 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\<nonsteroidal antiinflammatory drug\>)
• Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small saphenous vein (SSV).

You may not qualify if:

• Documented allergy or intolerance to compression hosiery
• Treated vein greater than 8.5 in diameters.
• Previous history of DVT(deep venous thrombosis); Known prothrombotic state.
• Arterial insufficiency as determined by ABI(ankle-brachial index)\<0.5.
• Obesity (BMI \>35, class II).

Sponsors & Collaborators

• NYC Surgical Associates: lead

Study Sites (1)

NYC Surgical Associates, 555 Passaic Ave, Suite 10

West Caldwell, New Jersey, 07006, United States

Location

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianzhong Huang, MD

  NYC Surgical Associates

  STUDY DIRECTOR

• David A Greuner, MD

  NYC Surgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

US (1)