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

ISRCTN	ISRCTN11604626
DOI	https://doi.org/10.1186/ISRCTN11604626
Secondary identifying numbers	N/A

Submission date: 04/11/2014
Registration date: 08/05/2015
Last edited: 08/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Guido Bruning
Scientific

Krankenhaus Tabea GmbH & Co. KG
Kösterbergstr. 32
Hamburg
22587
Germany

Study information

Study design	Randomized controlled prospective multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping: a prospective randomized multi-centre trial
Study acronym	CelArt
Study objectives	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(s)	Medical Council of Hamburg (Ärztekammer Hamburg), Germany, approved 10/06/2014 (confirmed amendments on 04/04/2014 and 13/05/2014), identification no. PV4495
Health condition(s) or problem(s) studied	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
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 study start date	10/11/2014
Completion date	09/10/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key 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)
Key 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)
Date of first enrolment	01/12/2014
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

Germany

Study participating centre

Krankenhaus Tabea GmbH & Co. KG

Hamburg
22587
Germany

Sponsor information

Artemed SE (Germany)
Industry

Bahnhofstraße 7
Munich
82327
Germany

Email	benjamin.behar@artemed.de
Website	http://www.artemed.de

Funders

Funder type

Other

Investigator initiated and funded (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan