Trials / Active Not Recruiting
Active Not RecruitingNCT02397226
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- University Hospital, Linkoeping · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Radiofrequency ablation | |
| PROCEDURE | High ligation/stripping | |
| DEVICE | Radiofrequency ablation catheter | |
| PROCEDURE | Tumescent anesthesia | |
| PROCEDURE | General anesthesia | |
| DEVICE | Vein stripping catheter |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2021-11-25
- Completion
- 2026-12-31
- First posted
- 2015-03-24
- Last updated
- 2024-12-06
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02397226. Inclusion in this directory is not an endorsement.