A randomized controlled trial comparing no compression therapy versus 4 hours of compressive therapy with a TED class II stocking after radiofrequency ablation for primary great saphenous vein incompetence

Recruiting

• Conditions: Varicose veins; venous insufficiency; 10057165

• Registration Number: NL-OMON40253
• Lead Sponsor: Atrium Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

- Patients with primary varicosity of the GSV, between age 18-80 year (C2 * C4 according to CEAP classification)
- Unilateral radiofrequency ablation (RFA)

Exclusion Criteria

- Ulcus cruris (C6 according to CEAP classification)
- Healed ulcus cruris (C5 according to CEAP classification)
- Non-compliance to therapy
- Bilateral radiofrequency ablation (RFA)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is edema of the leg, objectified by volume measurements on<br /><br>post-operative day 14, performed by the investigator (TA Sigterman or HG<br /><br>Rensma). A Perometer® (Bösl Medizintechnik, Aachen- Deutschland) will be used.<br /><br>This leg volume measurement will be performed on three standardized points on<br /><br>the leg: 10 cm above the upper edge of the patella, at the tuberosity of the<br /><br>tibia and 5 cm below the tuberosity of the tibia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to full recovery, post-operative pain and quality of life are secondary<br /><br>endpoints. The HRQOL will be estimated by the SF-36 questionnaire, which will<br /><br>be asked to fill in at randomization and after 2 weeks. At this point the<br /><br>patient will also be asked to determine the time in days to full recovery after<br /><br>the surgery. Post-operative pain will be scored by the patient on a<br /><br>standardized Visual Analogue Scale (VAS) from 1 to 10. Postoperative<br /><br>complications such as subcutaneous hematoma formation, thrombophlebitis and<br /><br>postoperative swelling will be documented. </p><br>