A randomized controlled trial comparing 4 hours of pressure bandage after radiofrequency ablation with standard aftercare for primary great saphenous vein incompetence

A randomized controlled trial comparing 4 hours of pressure bandage after radiofrequency ablation with standard aftercare for primary great saphenous vein incompetence - Compression therapy after RFA for GSV incompetence

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35851

Enrollment

100

Registered

2011-05-27

Start date

2011-10-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

varicosis venous incompetence

Interventions

After randomization patients will be allocated to either pressure bandage for 4 hours or a class II TEK stocking for 3 days

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is edema of the leg, objectified by volume measurements using a Perometer® (Bösl Medizintechnik, Aachen- Deutschland) at 3 moments: pre-operative, 3 days and 2 weeks	—

Secondary

Measure	Time frame
Post-operative pain, postoperative complications, time to full recovery and quality of life are secondary endpoints. Postoperative pain will be scored by the patient on a VAS scale from 0-10. The HRQOL will be estimated by the SF-36 questionnaire, which will be asked to fill in at randomization and after 2 weeks. Included will be the question to determine time to full recovery after the operation. Postoperative complications will be documented	—

Measure

Time frame

Post-operative pain, postoperative complications, time to full recovery and quality of life are secondary endpoints. Postoperative pain will be scored by the patient on a VAS scale from 0-10. The HRQOL will be estimated by the SF-36 questionnaire, which will be asked to fill in at randomization and after 2 weeks. Included will be the question to determine time to full recovery after the operation. Postoperative complications will be documented

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)