Varicose VeinsRAFPELSNCT00621062
Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence
A study testing High Ligation of the GSV, Endovenous Laser Ablation and Radiofrequency ablation in people with Varicose Veins, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- High Ligation of the GSV, Endovenous Laser Ablation and Radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Vascular Surgery; Central Hospital of Västerås
Västerås, 72189
About this study
Official title: 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.
- Conditions
- Varicose Veins
- Being tested
- High Ligation of the GSV, Endovenous Laser Ablation, Radiofrequency ablation, Foam Sclerotherapy
- Keywords
- varicose, vein, ligation, laser, foam, sclerotherapy, radiofrequency, duplex, sf36, Aberdeen, VCSS, quality, recurrence
- Medical subject headings
- Varicose Veins, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Ligation of the GSVProcedure or surgery
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.
Endovenous Laser AblationProcedure or surgery
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.
Radiofrequency ablationProcedure or surgery
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.
Foam SclerotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High Ligation of the GSV | Active comparator | Not described Receives: Procedure: High Ligation of the GSV |
| Endovenous Laser Ablation | Active comparator | Not described Receives: Procedure: Endovenous Laser Ablation |
| Radiofrequency ablation | Active comparator | Not described Receives: Procedure: Radiofrequency ablation |
| Foam Sclerotherapy | Active comparator | Not described Receives: Procedure: Foam Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
Measured: 3 years
Secondary outcomes (1)
Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Centrallasarettet Västerås
- Responsible party
- Sponsor
- Investigators
- Anders Hellberg, MD, PhD, Principal investigator, Dept. of Vascular Surgery, Central Hospital of VästeråsAdam Bersztel, MD, PhD, Principal investigator, Dept. of Vascular Surgery, Central Hospital of VästeråsJerszy Leppert, Professor, Study chair, Västerås Centrum for Clinical Research, University of UppsalaAchilleas Karkamanis, MD, Principal investigator, Dept. of Vascular Surgery, Central Hospital of Västerås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621062
- Sponsor's protocol ID
- RAFPELS
- Acronym
- RAFPELS
- Status last verified
- Mar 2011
- First submitted
- 12 Feb 2008
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial of Varicose Vein Surgery
- ClinicalTrials.gov ID
- NCT00621062
- Acronym / sponsor ID
- RAFPELS / RAFPELS
- Conditions
- Varicose Veins
- Keywords
- varicose, vein, ligation, laser, foam, sclerotherapy, radiofrequency, duplex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Centrallasarettet Västerås
- Study start
- Jan 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Ligation of the GSV | Active comparator | Procedure: High Ligation of the GSV |
| Endovenous Laser Ablation | Active comparator | Procedure: Endovenous Laser Ablation |
| Radiofrequency ablation | Active comparator | Procedure: Radiofrequency ablation |
| Foam Sclerotherapy | Active comparator | Procedure: Foam Sclerotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Ligation of the GSVPerformed 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. | Procedure or surgery | High Ligation of the GSV |
| Endovenous Laser AblationLaser 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. | Procedure or surgery | Endovenous Laser Ablation |
| Radiofrequency ablationRF 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. | Procedure or surgery | Radiofrequency ablation |
| Foam SclerotherapySclerosant 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. | Procedure or surgery | Foam Sclerotherapy |
Primary outcome
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
Time frame: 3 years
1 secondary outcome
Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Hellberg, MD, PhD principal investigator
Dept. of Vascular Surgery, Central Hospital of Västerås
Adam Bersztel, MD, PhD principal investigator
Dept. of Vascular Surgery, Central Hospital of Västerås
Jerszy Leppert, Professor study chair
Västerås Centrum for Clinical Research, University of Uppsala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Ligation of the GSV, Endovenous Laser Ablation and Radiofrequency ablation in people with Varicose Veins, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.