Condition category
Circulatory System
Date applied
04/11/2014
Date assigned
08/05/2015
Last edited
08/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Guido Bruning

ORCID ID

Contact details

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

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 measures

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

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

http://www.artemed.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes