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

NCT00621062 | Completed DMC

• 1 other identifier: RAFPELS
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Keywords

varicose; vein; ligation; laser; foam; sclerotherapy; radiofrequency; duplex; sf36; Aberdeen; VCSS; quality; recurrence

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (4)

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

Interventions

High Ligation of the GSV PROCEDURE

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.

High Ligation of the GSV

Endovenous Laser Ablation PROCEDURE

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.

Endovenous Laser Ablation

Radiofrequency ablation PROCEDURE

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.

Radiofrequency ablation

Foam Sclerotherapy PROCEDURE

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.

Foam Sclerotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Centrallasarettet Västerås: collaborator

Study Sites (1)

Department of Vascular Surgery; Central Hospital of Västerås

Västerås, 72189, Sweden

Location

MeSH Terms

Conditions

Varicose Veins; Recurrence

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Jerszy Leppert, Professor

  Västerås Centrum for Clinical Research, University of Uppsala

  STUDY CHAIR

• Achilleas Karkamanis, MD

  Dept. of Vascular Surgery, Central Hospital of Västerås

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 3, 2014

Record last verified: 2011-03

Locations

SE (1)