Clinical trial NCT00621062: Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence
Official title: Randomized Prospective Trial of Varicose Vein Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: varicose
vein
ligation
laser
foam
sclerotherapy
radiofrequency
duplex
sf36
Aberdeen
VCSS
quality
recurrence
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Centrallasarettet Västerås
First posted: 2008-02-22
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through a prospective RCT evaluate and compare the three new endovenous methods for great saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome) factors will be studied.


Eligibility criteria: Inclusion Criteria:

* Clinical examinations by an experienced surgeon as well as duplex evaluation. Duplex evaluation of both the deep and the superficial system is required but not of the perforating vessels. It is performed by experienced BMA or surgeon with profound knowledge in vein diagnosis with duplex.
* Patients with primary varicose vein disease between age 18 to 75.
* Signature of informed consent.
* Varicose veins and duplex verified GSV incompetence defined as \>0,5 seconds reflux time after manual compression in upright position 60 degrees.
* Vein size \<20 mm in upright position 60 degrees, 2 cm below the SFJ.
* Minimum distance between skin and the GSV in the first 20 cm from the SFJ \> 5mm.
* CEAP classification C2-C5
* BMI \<35

Exclusion Criteria:

* Non-consent for randomisation.
* Age \<18 years.
* Age \>75 years.
* Deep vein insufficiency in the same extremity (duplex verified).
* Vein size \>20mm in upright position 60 degrees below the SFJ.
* Meander and superficial veins with a distance of \<5mm to the skin surface ( RF or Laser cannot be applied).
* Patients with double GSV's and/or lateral accessory insufficient branch.
* Patients with cognitive disturbances, dementia or unable to understand for any reason the importance of follow up.
* Earlier operation with HL/S (recurrency).
* Operated for small saphenous vein (SSV) incompetence the last 3 months.
* Known ABI \<0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
* Patients with recent cancer diagnosis or undergoing cancer treatment.
* BMI \>35.
* Patients with other known medical condition that contradict any of the treatments in the study.
* Minimum distance between skin and the GSV in the first 20 cm from the SFJ \>5mm.

Primary outcomes:
measure: Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
timeFrame: 3 years
Secondary outcomes:
measure: Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.
timeFrame: 3 years
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Department of Vascular Surgery; Central Hospital of Västerås
Study officials:
affiliation: Dept. of Vascular Surgery, Central Hospital of Västerås
name: Anders Hellberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Vascular Surgery, Central Hospital of Västerås
name: Adam Bersztel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Västerås Centrum for Clinical Research, University of Uppsala
name: Jerszy Leppert, Professor
role: STUDY_CHAIR
affiliation: Dept. of Vascular Surgery, Central Hospital of Västerås
name: Achilleas Karkamanis, MD
role: PRINCIPAL_INVESTIGATOR
References: