A randomized controlled trial comparing 4 hours of pressure bandage after radiofrequency ablation with standard aftercare for primary great saphenous vein incompetence
Completed
- Conditions
- varicosisvenous incompetence10057165
- Registration Number
- NL-OMON35851
- Lead Sponsor
- Atrium Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
- patients with primary varicosity of the GSV, between age 18-80 year (C2 * C4 according to CEAP classification)
- unilateral radiofrequency ablation
Exclusion Criteria
- ulcus cruris (C6 according to CEAP classification)
- healed ulcus cruris (C5 according to CEAP classification)
- non-compliance to wearing pressure bandage
- bilateral radiofrequency ablation
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<br /><br>using a Perometer® (Bösl Medizintechnik, Aachen- Deutschland) at 3 moments:<br /><br>pre-operative, 3 days and 2 weeks</p><br>
- Secondary Outcome Measures
Name Time Method <p>Post-operative pain, postoperative complications, time to full recovery and<br /><br>quality of life are secondary endpoints. Postoperative pain will be scored by<br /><br>the patient on a VAS scale from 0-10. The HRQOL will be estimated by the SF-36<br /><br>questionnaire, which will be asked to fill in at randomization and after 2<br /><br>weeks. Included will be the question to determine time to full recovery after<br /><br>the operation. Postoperative complications will be documented</p><br>