Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping

Not Applicable

Completed

• Conditions: Great saphenous vein insufficiency; Circulatory System; Venous insufficiency (chronic) (peripheral)

• Registration Number: ISRCTN11604626
• Lead Sponsor: Artemed SE (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Great saphenous vein (GSV) insufficiency with saphenofemoral incompetence and reflux at least down to the knee level
2. Chronic venous insufficiency and/or symptoms caused by GSV incompetence
3. Diameter of GSV at measuring point 3 cm distal of the junction vena epigastrica superficialis (VES) maximal 15 mm in standing position
4. Performance status according to American Society of Anesthesiology (ASA) I-II
5. Surgical procedure in tumescent local anesthesia (TLA) or total intravenous anesthseia (TIVA) in combination with TLA
6. Written consent
7. Distance of place of residence to study centre <= 150 km
8. Age 18 - 70 years (at randomisation)

Exclusion Criteria

1. Incompetence of vena saphena parva (VSP) requiring treatment at the same limb, anterior accessory vein incompetence requiring treatment at the same limb
2. Previous sclerotherapy of VSM, previous endovenous treatment of VSM, previous surgical interventions in the groin area
3. Recurrences in the groin area
4. Permanent oral anticoagulation with e.g, Marcumar, Warfarin, Rivaroxaban
5. Acute thrombophlebitis, deep venous thrombosis or post-thrombotic syndrome (post-thrombotic syndrome), incompetence of deep veins (vena femoralis superficialis and vena poplitea)
6. Known thrombophilia associated with a high risk of thromboembolism
7. Arterial occlusive disease > Fontaine IIA
8. Polyneuropathia
9. Performance status according to American Society of Anesthesiology (ASA) III - VI
10. Active malignancy (diagnosed during the past 5 years)
11. Females pregnant or nursing
12. Distance of place of residence to study centre > 150 km
13. No written consent
14. Age <18 or >70 years (at randomisation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life, benefit for the patients and patients' satisfaction is measured using visual analogue scale (VAS) based questionnaires, pain scale according to VAS, Venous Clinical Severity Score (VCSS), Patient Benefit Index (PBI-v[prä] and PBI-v[post]) and Freiburger quality of life questionnaire for veins (FLAQvs) and open-ended questionnaire. Measured at preoperative visit and after 3 months, 1 year, 2 years, 3 years, 4 years and<br>5 years.

Secondary Outcome Measures

Name	Time	Method
1. Minor and major complications<br>2. Recurrent varices after treatment (REVAT) evaluated at 3, 6, 12, 24, 36, 48 and 60 months follow-up visit