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

Varicose Veins Clinical Trial

— RAFPELS  

Official title:

Randomized Prospective Trial of Varicose Vein Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621062
• Other study ID #: RAFPELS
• Status: Completed
• Phase: N/A
• First received: February 12, 2008
• Last updated: January 31, 2014
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: March 2011
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Department of Vascular Surgery; Central Hospital of Västerås	Västerås

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Centrallasarettet Västerås

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.		3 years	Yes
Secondary	Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.		3 years	No