Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg

NCT05766579 | Recruiting DMC

• 1 other identifier: 41/int/2019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications. Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols. There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.

Conditions

Vascular Surgical Procedures

Keywords

Stockings, Compression; Thermoablation; Radiofrequency; Saphenous Vein

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)

  3 days after surgery

• Postoperative Pain

  Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)

  7 days after surgery

Secondary Outcomes (15)

• Lower limb edema

  3 days from intervention

• Lower limb edema

  7 days from intervention

• Lower limb edema

  30 days from intervention

• Analgesic Drugs Use

  3 days from intervention

• Analgesic Drugs Use

  7 days from intervention

Study Arms (2)

K1, 18-21 mmHg

EXPERIMENTAL

Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation

Device: Elastic-compressive stockings

K2, 23-32 mmHg

EXPERIMENTAL

Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation

Device: Elastic-compressive stockings

Interventions

Elastic-compressive stockings DEVICE

Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.

K1, 18-21 mmHg; K2, 23-32 mmHg

Eligibility Criteria

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

You may qualify if:

• adult patients (\>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

You may not qualify if:

• Patients who are minors (\< 18 years old) or adults who have not given their consent to participate in the study.
• Presence of severe obliterating arterial disease of the lower limbs (ABI \<0.5)
• Obesity (BMI \>30)
• Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:
• lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).
• Pregnancy.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (14)

• 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

• Onida S, Lane TR, Davies AH. Phlebectomies: to delay or not to delay? Phlebology. 2012 Apr;27(3):103-4. doi: 10.1258/phleb.2012.011130. No abstract available.

  PMID: 22457169 BACKGROUND

• Huang TW, Chen SL, Bai CH, Wu CH, Tam KW. The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials. Eur J Vasc Endovasc Surg. 2013 Apr;45(4):397-402. doi: 10.1016/j.ejvs.2013.01.030. Epub 2013 Feb 19.

  PMID: 23433496 BACKGROUND

• Reich-Schupke S, Feldhaus F, Altmeyer P, Mumme A, Stucker M. Efficacy and comfort of medical compression stockings with low and moderate pressure six weeks after vein surgery. Phlebology. 2014 Jul;29(6):358-66. doi: 10.1177/0268355513484142. Epub 2013 May 3.

  PMID: 23563646 BACKGROUND

• Ye K, Wang R, Qin J, Yang X, Yin M, Liu X, Jiang M, Lu X. Post-operative Benefit of Compression Therapy after Endovenous Laser Ablation for Uncomplicated Varicose Veins: A Randomised Clinical Trial. Eur J Vasc Endovasc Surg. 2016 Dec;52(6):847-853. doi: 10.1016/j.ejvs.2016.09.005. Epub 2016 Oct 17.

  PMID: 27760697 BACKGROUND

• Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5.

  PMID: 24012465 BACKGROUND

• Cavezzi A, Mosti G, Colucci R, Quinzi V, Bastiani L, Urso SU. Compression with 23 mmHg or 35 mmHg stockings after saphenous catheter foam sclerotherapy and phlebectomy of varicose veins: A randomized controlled study. Phlebology. 2019 Mar;34(2):98-106. doi: 10.1177/0268355518776127. Epub 2018 May 12.

  PMID: 29754530 BACKGROUND

• El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Wallace T, Campbell B, Chetter IC. A systematic review of the compression regimes used in randomised clinical trials following endovenous ablation. Phlebology. 2017 May;32(4):256-271. doi: 10.1177/0268355516648497. Epub 2016 May 12.

  PMID: 27178404 BACKGROUND

• Weiss RA, Duffy D. Clinical benefits of lightweight compression: reduction of venous-related symptoms by ready-to-wear lightweight gradient compression hosiery. Dermatol Surg. 1999 Sep;25(9):701-4. doi: 10.1046/j.1524-4725.1999.99064.x.

  PMID: 10491060 BACKGROUND

• Benigni JP, Sadoun S, Allaert FA, Vin F. Efficacy of Class 1 elastic compression stockings in the early stages of chronic venous disease. A comparative study. Int Angiol. 2003 Dec;22(4):383-92.

  PMID: 15153823 BACKGROUND

• Liu R, Lao TT, Kwok YL, Li Y, Ying MT. Effects of graduated compression stockings with different pressure profiles on lower-limb venous structures and haemodynamics. Adv Ther. 2008 May;25(5):465-78. doi: 10.1007/s12325-008-0058-2.

  PMID: 18523736 BACKGROUND

• El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Campbell B, Chetter IC. Systematic review of compression following treatment for varicose veins. Br J Surg. 2015 Jun;102(7):719-25. doi: 10.1002/bjs.9788. Epub 2015 Apr 2.

  PMID: 25833417 BACKGROUND

• Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care. 1993 Mar;2(1):5-10. doi: 10.1136/qshc.2.1.5.

  PMID: 10132081 BACKGROUND

• Krasznai AG, Sigterman TA, Troquay S, Houtermans-Auckel JP, Snoeijs M, Rensma HG, Sikkink C, Bouwman LH. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology. 2016 Mar;31(2):118-24. doi: 10.1177/0268355514568658. Epub 2015 Jan 23.

  PMID: 25616874 BACKGROUND

Central Study Contacts

Daniela Mazzaccaro, MD, PhD

CONTACT

+ 39 025277; daniela.mazzaccaro@grupposandonato.it

Giovanni Nano, MD, PhD

CONTACT

+ 39 025277; giovanni.nano@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor and Researcher

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 13, 2023
• Study Start: April 2, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)