Clinical Trials Logo

Clinical Trial Summary

A double blind randomised controlled trial of radiofrequency thermal ablation treatments of great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency.

Assessments by visual pain scores, duplex ablation and quality of life questionaires


Clinical Trial Description

Purpose To establish which of the radiofrequency venous ablation modalities is most effective in preventing reflux in the treated segment of GSV six months following surgery.

Design Results of randomised trials and meta-analyses have shown that endovenous thermal ablation using radiofrequency ablation and laser are associated with improved recovery compared with conventional surgery on the GSV. Further, radiofrequency (Closurefast) has been showed to cause less pain and require less analgesic intake than laser. There are two other radiofrequency devices that have theoretical advantages over the Closurefast technique. All three procedures have been used in clinical practice (including at Worcestershire Royal Hospital). There has been no trial to date which has directly compared the outcomes of the three radiofrequency thermal ablation devices.

Recruitment Patients will be recruited from Worcestershire Acute Hospitals NHS Trust vascular surgical out-patient clinics. All patients will receive a duplex scan (Toshiba Viamo Ultrasound, Tokyo, Japan or Sonosite M-Turbo Bothell, Washington, USA) prior to entry into the trial to confirm their suitability for endovenous thermal ablation treatment. During this assessment patients will also have their CEAP (Clinical, Etiological, Anatomical, and Pathophysiological) classification of severity and aetiology of venous disease score recorded. If the patient consents to the trial they will be asked to fill in the disease specific Aberdeen Varicose Vein Questionnaire (AVVQ)and generic quality of life SF-36 and Euroquol (EQ-5D) questionnaires and have their Venous Clinical Severity Score (VCSS) calculated.

Patients will be recruited to the trial following an appropriate explanation of the study (see patient information / consent sheet). Randomisation will be performed by a random number generator (www.random.org).

Patients will be randomised to radiofrequency ablation either by Closurefast (Venefit, VNUS Medical Technologies, Inc., Sunnyvale, CA), the Radiofrequency induced Thermal Therapy (RFiTT, Olympus Surgical Technologies Europe, Hamburg, Germany) or EndoVenous Radiofrequency (EVRF, Medical Innovations, Bolton, United Kingdom). All treatments are already in use in Worcestershire.

Operation All treatments will be performed under local tumescent anaesthesia. Patients will receive thromboprophylaxis when indicated in line with the Hospital Trust's local thromboprophylaxis protocol. Procedures will be performed under duplex control (Sonosite M-Turbo, Bothell, Washington, USA) by an experienced vascular surgery Specialist Registrar or Consultant. The GSV will be catheterised percutaneously using a Seldinger technique at the level of the lowest point of reflux. The radiofrequency treatment catheter will be passed endoluminally to the level of the sapheno-femoral junction. Tumescent anaesthesia (50mg Prilocaine, 10mls 8.4% sodium bicarbonate in 1000mls 0.9% saline) will be injected in the peri-venous space in all patients (200 - 500ml). The position of the radiofrequency catheter will be confirmed just below the level of the sapheno-femoral junction prior to commencing the radiofrequency current and withdrawing the catheter to treat the vein in line with local practice. The Closurefast is withdrawn after a double treatment of the most proximal segment of the long saphenous vein and then segmentally thereafter, the RFiTT will be withdrawn continuously with retreatments, and the EVRF will be withdrawn in small stepwise movements (all as per the manufacturer's instructions for use). The volume of anaesthetic administered, length of vein treated and duration of the ablation will be recorded.

In line with current NICE guidance (CG168), where necessary, patients will undergo avulsions of local varicosities at the same time. The number of avulsions will be recorded in both groups. Perforating veins will not be directly treated. Treated legs will be dressed with dressing pads a full length bandage (coban, 3M United Kingdom plc, Bracknell, Berkshire, UK) and compression hosiery. Patients will be discharged on the day of surgery (day-case) with oral analgesia as required and will be given contact information should any adverse events arise.

Post-operative follow-up

i) First week Patients will be asked to keep a pain score for the first post-operative week. This is a simple 10cm visual analogue score. All patients will be invited back to clinic at two weeks for a duplex scan (blind assessment). During this visit the vascular team will assess any complications in the area of ablation including bruising (digital photographic record), wound infection, neuralgia, deep vein thrombosis and pulmonary embolus.

ii) Six months The primary endpoint of the study is an ablated GSV. Treatment failure will be defined as any segment of the treated trunk (> 2cm from the saphenofemoral junction) that is patent (compressible) and demonstrates reflux (>1 second) on duplex scanning.

A number of secondary outcome measures will be evaluated in the study:

Pain score/ analgesic requirements

Time to return to normal activity

Absence or recurrent varicose veins/return of symptoms

Quality Of Life (QoL): Disease specific (AVVQ) and generic (EQ5D & SF36) quality of life assessments will be compared at 1 weeks post treatment, 6 months and 12 months. The 1-week questionnaire will be given to the patient at discharge, whereas other QoL questionnaires will be sent to the patient. AVVQ is the most widely utilised disease specific QoL tool in venous disease and has been extensively validated. A score out of 100 points is calculated, with a higher score indicating more severe QoL impairment.

Other Markers Of Clinical Success: The Venous Clinical Severity Score (VCSS) will be assessed at 6 months. In addition, the incidence of complications related to the endovenous intervention as well as the presence of residual / recurrent varicose veins will also be assessed at 2 weeks.

Medium and longer-term endpoints (follow-up) will be performed at 2 years and 5 years. However, this is likely to be limited by the high rates (>20%) of drop-out reported in other studies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02441881
Study type Interventional
Source Worcestershire Acute Hospitals NHS Trust
Contact
Status Completed
Phase N/A
Start date September 5, 2014
Completion date September 30, 2017

See also
  Status Clinical Trial Phase
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Recruiting NCT02676908 - Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery N/A
Withdrawn NCT01426035 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment Phase 3
Withdrawn NCT01203397 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment Phase 3
Recruiting NCT02054325 - Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins Phase 4
Withdrawn NCT03601572 - Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
Completed NCT04933591 - Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood N/A
Active, not recruiting NCT02397226 - Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery N/A
Withdrawn NCT02936271 - Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting N/A
Terminated NCT02557542 - Pilot RCT Evaluating a One Stop Vein Clinic N/A
Completed NCT00758420 - Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence Phase 2/Phase 3
Active, not recruiting NCT00841178 - Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT N/A
Not yet recruiting NCT05508581 - Microwaves Ablation of Varicose Veins N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Active, not recruiting NCT04339075 - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Completed NCT03392753 - Mechanochemical Ablation Compared to Cyanoacrylate Adhesive N/A
Recruiting NCT04146168 - Lake Washington Vascular VenaSealâ„¢ Post-Market Evaluation
Recruiting NCT02304146 - Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study N/A
Completed NCT01200199 - Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Completed NCT01231373 - Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence Phase 3