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

January 31, 2014 updated by: Uppsala University

Randomized Prospective Trial of Varicose Vein Surgery

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Västerås, Sweden, 72189
        • Department of Vascular Surgery; Central Hospital of Västerås

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: 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
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

March 1, 2011

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Varicose Veins

Clinical Trials on High Ligation of the GSV

3
Subscribe