Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence (RAFPELS)

This study has been completed.
Sponsor:
Collaborator:
Centrallasarettet Västerås
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT00621062
First received: February 12, 2008
Last updated: January 31, 2014
Last verified: March 2011
  Purpose

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.


Condition Intervention
Varicose Veins
Procedure: High Ligation of the GSV
Procedure: Endovenous Laser Ablation
Procedure: Radiofrequency ablation
Procedure: Foam Sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial of Varicose Vein Surgery

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 540
Study Start Date: January 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Ligation of the GSV Procedure: High Ligation of the GSV
Performed in local or general anesthesia in accordance to clinical praxis and the patients own preference. After high ligation the GSV is stripped from the groin to the most distant insufficient part or just under the knee joint.All proximal branches are ligated. Including the superficial epigastric vein. The stripping instrument can be inserted in either cranial or caudal direction but all veins are stripped in the cranio-caudal direction.
Active Comparator: Endovenous Laser Ablation Procedure: Endovenous Laser Ablation
Laser ablation is performed in tumescence anesthesia which is performed with a 150-200 ml (sometimes more is required, up to 400ml in patients with a poorly formed saphenous sheath) solution of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). Laser is performed under duplex guidance and the catheter is inserted percutaneously into the GSV at knee level and parked distant to the saphenofemoral junction (SFJ) just distal to the superficial epigastric vein. Laser ablation is performed down to the most distal insufficient part of GSV or just below the knee joint. We use an effect of 14 Watt administration of 70-80 J / cm at a continuous mode at a speed of 1cm/5sec.
Active Comparator: Radiofrequency ablation Procedure: Radiofrequency ablation
RF ablation is performed in tumescence anesthesia which is performed with a 150-200 ml solution (same as above) of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). RF is performed under duplex guidance and the Closure-FAST catheter is inserted percutaneously into the GSV at the knee level and parked distant to the SFJ just distal to the superficial epigastric vein. Probe size and length used for RF is chosen in accordance to the manufacturer's recommendation and with a probe temperature of 120 degrees C. RF closure is performed down to the most distal insufficient part of GSV or just under the knee joint.
Active Comparator: Foam Sclerotherapy Procedure: Foam Sclerotherapy
Sclerosant foam consists of 2ml 3% aethoxysclerol mixed with 8ml air (Tessari method). A maximum of 10 ml is injected. Access to the vein for the sclerosant is gained by a duplex guided puncture or a mini incision mid-thigh or just above the knee and the amount of sclerosant foam used is 2,5-10 ml. Duplex is used prior to the operation in order to mark the vein and during the operation in order to control the extent of the sclerofoam. Duplex validates that foam is deposed to the whole length of the GSV. Blood from the veins is drained by means of elevation prior to the deposition of the sclerofoam. The leg is then bandaged with elastic bandage.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621062

Locations
Sweden
Department of Vascular Surgery; Central Hospital of Västerås
Västerås, Sweden, 72189
Sponsors and Collaborators
Uppsala University
Centrallasarettet Västerås
Investigators
Principal Investigator: Anders Hellberg, MD, PhD Dept. of Vascular Surgery, Central Hospital of Västerås
Principal Investigator: Adam Bersztel, MD, PhD Dept. of Vascular Surgery, Central Hospital of Västerås
Study Chair: Jerszy Leppert, Professor Västerås Centrum for Clinical Research, University of Uppsala
Principal Investigator: Achilleas Karkamanis, MD Dept. of Vascular Surgery, Central Hospital of Västerås
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT00621062     History of Changes
Other Study ID Numbers: RAFPELS
Study First Received: February 12, 2008
Last Updated: January 31, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
varicose
vein
ligation
laser
foam
sclerotherapy
radiofrequency
duplex
sf36
Aberdeen
VCSS
quality
recurrence

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014