Plain English Summary
Background and study aims
Varicose veins are swollen and enlarged veins that usually occur on the legs. They can be treated with surgery to remove the affected veins or with thermotherapy, in which the affected veins are burned and closed. At the moment there is not enough evidence regarding the benefits of the different treatments for varicose veins, especially for thermotherapy. The aim of our study is to find out whether thermotherapy provides better results compared with surgery.
Who can participate?
Patients aged 18 - 70 with varicose veins.
What does the study involve?
Participants will be randomly allocated to undergo either thermotherapy or surgery. The participants will be followed-up regularly for 5 years after the treatment.
What are the possible benefits and risks of participating?
By entering the study participants get the chance to try a new treatment for free.
Where is the study run from?
Krankenhaus Tabea (Germany).
When is the study starting and how long is it expected to run for?
From November 2014 to October 2019.
Who is funding the study?
Artemed SE (Germany).
Who is the main contact?
Dr Guido Bruning
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping: a prospective randomized multi-centre trial
Acronym
CelArt
Study hypothesis
Quality of life and benefit for the patient is higher 5 years after bipolar radio frequency induced thermotherapy (RFITT) compared with high ligation (crossectomy) and stripping.
Ethics approval
Medical Council of Hamburg (Ärztekammer Hamburg), Germany, approved 10/06/2014 (confirmed
amendments on 04/04/2014 and 13/05/2014), identification no. PV4495
Study design
Randomized controlled prospective multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Great saphenous vein insufficiency
Intervention
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.
Intervention type
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
10/11/2014
Overall trial end date
09/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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)
Recruitment start date
01/12/2014
Recruitment end date
01/12/2015
Locations
Countries of recruitment
Germany
Trial participating centre
Krankenhaus Tabea GmbH & Co. KG
Hamburg
22587
Germany
Sponsor information
Organisation
Artemed SE (Germany)
Sponsor details
Bahnhofstraße 7
Munich
82327
Germany
-
benjamin.behar@artemed.de
Sponsor type
Industry
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list