search
Back to results

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

Primary Purpose

Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High Ligation of the GSV
Endovenous Laser Ablation
Radiofrequency ablation
Foam Sclerotherapy
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring varicose, vein, ligation, laser, foam, sclerotherapy, radiofrequency, duplex, sf36, Aberdeen, VCSS, quality, recurrence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Vascular Surgery; Central Hospital of Västerås

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High Ligation of the GSV

Endovenous Laser Ablation

Radiofrequency ablation

Foam Sclerotherapy

Arm Description

Outcomes

Primary Outcome Measures

Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.

Secondary Outcome Measures

Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.

Full Information

First Posted
February 12, 2008
Last Updated
January 31, 2014
Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås
search

1. Study Identification

Unique Protocol Identification Number
NCT00621062
Brief Title
Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence
Acronym
RAFPELS
Official Title
Randomized Prospective Trial of Varicose Vein Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
varicose, vein, ligation, laser, foam, sclerotherapy, radiofrequency, duplex, sf36, Aberdeen, VCSS, quality, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Ligation of the GSV
Arm Type
Active Comparator
Arm Title
Endovenous Laser Ablation
Arm Type
Active Comparator
Arm Title
Radiofrequency ablation
Arm Type
Active Comparator
Arm Title
Foam Sclerotherapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
High Ligation of the GSV
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endovenous Laser Ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Foam Sclerotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Hellberg, MD, PhD
Organizational Affiliation
Dept. of Vascular Surgery, Central Hospital of Västerås
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Bersztel, MD, PhD
Organizational Affiliation
Dept. of Vascular Surgery, Central Hospital of Västerås
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerszy Leppert, Professor
Organizational Affiliation
Västerås Centrum for Clinical Research, University of Uppsala
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Achilleas Karkamanis, MD
Organizational Affiliation
Dept. of Vascular Surgery, Central Hospital of Västerås
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular Surgery; Central Hospital of Västerås
City
Västerås
ZIP/Postal Code
72189
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs