ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	17 October 2016
Main ID:	ISRCTN11604626
Date of registration:	08/05/2015
Prospective Registration:	No
Primary sponsor:	Artemed SE (Germany)
Public title:	Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping
Scientific title:	Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping: a prospective randomized multi-centre trial
Date of first enrolment:	01/12/2014
Target sample size:	200
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN11604626
Study type:	Interventional
Study design:	Randomized controlled prospective multi-centre trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Guido Bruning
Address:	Krankenhaus Tabea GmbH & Co. KG Kösterbergstr. 32 22587 Hamburg Germany
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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: 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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 Ligation (Crossectomy) and Stripping (HLS): Standard surgical procedures are performed, consisting of transection of all groin tributaries, flush ligation of the saphenofemoral junction with resorbable sutures and neoreflux protection with a continuous stump suture, followed by invagination stripping of the great saphenous vein just below knee under tumescent local anaesthesia. The additional phlebectomy of side branches is allowed.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded (Germany)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.