Comparison Of The Outcomes Of Simultaneous Laser Treatment And Injection Sclerotherapy Versus Laser Treatment Alone In Patients With Varicose Veins of Legs

Not yet recruiting

• Conditions: Varicose veins of lower extremities with both ulcer and inflammation,

• Registration Number: CTRI/2019/04/018703
• Lead Sponsor: AIIMS

Brief Summary

Varicose veins are extremely common worldwide . Currently, endovenous thermal ablations and foam sclerotherapy are the standard of care for chronic venous reflux disease. Residual varicose veins-associated symptoms and cosmetic issues are becoming a matter of clinical controversy. Usually, endovenous laser ablation is done alone followed by a staged sclerotherapy if required at 6-8weeks. In recently published randomized controlled trials (RCTs), concomitant phlebectomy with truncal treatment reduced the need for staged procedures and improved quality of life (QoL). Simultaneous treatment of varicose veins may increase operative time and outpatient discomfort. However, this combination procedure significantly reduces the number of patients who need a staged treatment of residual varicose veins for cosmetic and symptomatic reasons. Clinical safety, feasibility, and effectiveness of simultaneous EVLA and FS have not yet been fully confirmed in a randomized study till date. The aim of this study was to compare the outcomes of patients who received simultaneous  EVLA and FS with those receiving truncal lasering alone in single sitting.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-75years, informed consent b.
• C2-6, Epr, A s, according to the CEAP classification (clinical, etiologic, anatomical, and pathophysiological (CEAP) ) c.
• Primary signs and symptoms of truncal(saphenous, accessory, non saphenous) vein incompetence/relux with reflux time of 1 sec or more on Doppler, and diameter of varicose veins more than 3mm and less than 15mm, diameter of perforator >3mm.
• an accessible vein.

Exclusion Criteria

• 1.Any patient who doesn’t give consent for being included in the study.
• 2.Evidence of peripheral arterial disease 3.any previous treatment, such as surgery, EVLA, radiofrequency ablation, or FS, for ipsilateral varicosity.
• 4.lower limb varicosity caused by deep venous thrombosis.
• 5.coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health, or allergy to sodium tetradecyl sulfate (STS) 6.
• Contraindication to iodinated contrast media.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aberdeen Varicose Vein Questionnaire (AVVQ)	24 hours, 1 week, 4 weeks, 3months and 6months after procedure

Secondary Outcome Measures

Name	Time	Method
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D), numerical rating scale (NRS) scores, CEAP score	24 hours, 1 week, 4 weeks, 3months and 6months after procedure

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 West, DELHI, India

AIIMS, New Delhi

🇮🇳West, DELHI, India

Dr Vineeta Ojha

Principal investigator

9051721696

vineetao17@gmail.com