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

Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping: a prospective randomized multi-centre trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11604626

Enrollment

200

Registered

2015-05-08

Start date

2014-12-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Great saphenous vein insufficiency Circulatory System Venous insufficiency (chronic) (peripheral)

Interventions

Group A: ultrasound-guided bipolar radio frequency induced thermotherapy (RFITT) is performed under tumescent local anaesthesia. The additional phlebectomy of side branches is allowed. Group B: High

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 70 years (at randomisation)

Design outcomes

Primary

Measure	Time frame
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 5 years.	—

Measure

Time frame

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 5 years.

—

Secondary

Measure	Time frame
1. Minor and major complications 2. Recurrent varices after treatment (REVAT) evaluated at 3, 6, 12, 24, 36, 48 and 60 months follow-up visit	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026