Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

NCT02588911 | Completed

• 1 other identifier: RFA vs CS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).

Conditions

Venous Insufficiency

Keywords

Radiofrequency Catheter Ablation; Operative Surgical Procedure; Saphenous Vein

Outcome Measures

Primary Outcomes (10)

• Change in intensity of hyper pigmentation using a scale of 0 to 10

  Patients and physicians were oriented to indicate their subjective perception of intensity of hyperpigmentation on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  One week, one month and six months after surgery

• Change in extension of hematoma using a scale of 0 to 10

  Patients and physicians were oriented to indicate their subjective perception of extension of hematoma on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  One week, one month and six months after surgery

• Change in aesthetic results using a scale of 0 to 10

  Patients and physicians were oriented to indicate their subjective perception of aesthetic results on a scale of 0 (unaesthetic) to 10 (excellent results).

  One week, one month and six months after surgery

• Change in pain levels using a scale of 0 to 10

  Patients were asked to indicate pain levels on a scale of 0 (no pain) to 10 (worst imaginable pain).

  One week, one month and six months after surgery

• Change in intensity of skin burns using a scale of 0 to 10

  Physicians were asked to inform intensity of skin burns on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  One week, one month and six months after surgery

• Change in presence of sensitivity alteration

  Patients were asked to indicate the presence or absence of sensitivity alteration.

  One week, one month and six months after surgery

• Change in presence of thrombophlebitis

  Physicians were asked to inform the presence or absence of thrombophlebitis.

  One week, one month and six months after surgery

• Change in presence of resection or occlusion of the great saphenous vein

  Duplex ultrasound scan was used to evaluate the presence or absence of resection or occlusion (success rate) of the great saphenous vein.

  One month, six months and 12 months after surgery

• Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein

  Duplex ultrasound scan was used to evaluate the presence or absence of reflux in the sapheno-femoral junction and in the great saphenous vein

  One month, six months and 12 months after surgery

• Change in presence of complications

  Duplex ultrasound scan was used to evaluate the presence or absence of complications such as deep vein thrombosis (DVT) and lymphocele.

  One month, six months and 12 months after surgery

Study Arms (2)

Conventional Surgery

ACTIVE COMPARATOR

Limb with GSV insufficiency in the same patient, randomised to conventional surgery

Procedure: Conventional Surgery

Radiofrequency Ablation

ACTIVE COMPARATOR

Limb with GSV insufficiency in the same patient, randomised to radiofrequency ablation

Procedure: Radiofrequency Ablation

Interventions

Conventional Surgery PROCEDURE

Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein

Conventional Surgery

Radiofrequency Ablation PROCEDURE

Catheter-based ablation of the great saphenous vein

Radiofrequency Ablation

Eligibility Criteria

• Age: 33 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 60 years
• Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
• Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)

You may not qualify if:

• Patients able to give informed consent
• Varicose veins without GSV insufficiency on duplex scan
• Previous varicose vein surgery
• Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
• GSV diameter \<3 mm or \>12 mm in the supine position
• Thrombus in the GSV
• Patients with a pacemaker or internal defibrillator
• Concomitant peripheral arterial disease (ankle-brachial pressure index of \<0.9)
• Patients on oral anticoagulants
• Patients with high blood pressure not controlled by medication
• Patients with known thrombophilia, cancer or lupus
• Pregnancy

Sponsors & Collaborators

• Nelson Wolosker: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Related Publications (6)

• Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available.

  PMID: 25920631 BACKGROUND

• Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.

  PMID: 22705163 BACKGROUND

• Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg. 2006 Feb;31(2):212-8. doi: 10.1016/j.ejvs.2005.07.005. Epub 2005 Aug 31.

  PMID: 16137898 BACKGROUND

• Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD. Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.

  PMID: 20537570 BACKGROUND

• Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29.

  PMID: 19879166 BACKGROUND

• Mendes CA, Martins AA, Fukuda JM, Parente JB, Munia MA, Fioranelli A, Teivelis MP, Varella AY, Caffaro RA, Kuzniec S, Wolosker N. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know. Clinics (Sao Paulo). 2016 Nov 1;71(11):650-656. doi: 10.6061/clinics/2016(11)06.

  PMID: 27982166 DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nelson Wolosker, MD, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

BR (1)