- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00621062
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
Status
Completed
Conditions
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
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Västerås, Sweden, 72189
- Department of Vascular Surgery; Central Hospital of Västerås
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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
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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.
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Active Comparator: High Ligation of the GSV
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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.
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Active Comparator: Endovenous Laser Ablation
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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.
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Active Comparator: Foam Sclerotherapy
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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.
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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
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3 years
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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
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAFPELS
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.
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