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

ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Surgical Procedures
• Intervention / Treatment: Device: Elastic-compressive stockings

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Mazzaccaro, MD, PhD; Phone Number: 4341 + 39 025277; Email: daniela.mazzaccaro@grupposandonato.it
• Study Contact Backup: Name: Giovanni Nano, MD, PhD; Phone Number: 4341 + 39 025277; Email: giovanni.nano@grupposandonato.it

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • Recruiting
      • I.R.C.C.S. Policlinico San Donato
      • Contact: Daniela Mazzaccaro, MD, PhD; Phone Number: 4341 + 39 025277; Email: daniela.mazzaccaro@grupposandonato.it
      • Contact: Giovanni Nano, MD, PhD; Phone Number: 4341 + 39 025277; Email: giovanni.nano@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K1, 18-21 mmHg; Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation	Device: Elastic-compressive stockings; Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.
Experimental: K2, 23-32 mmHg; Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation	Device: Elastic-compressive stockings; Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb edema	Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter	3 days from intervention
Lower limb edema	Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter	7 days from intervention
Lower limb edema	Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter	30 days from intervention
Analgesic Drugs Use	Evaluation of the possible use of analgesic drugs for postoperative pain.	3 days from intervention
Analgesic Drugs Use	Evaluation of the possible use of analgesic drugs for postoperative pain.	7 days from intervention
Analgesic Drugs Use	Evaluation of the possible use of analgesic drugs for postoperative pain.	30 days from intervention
Discomfort	Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .	3 days from intervention
Discomfort	Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .	7 days from intervention
Discomfort	Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .	30 days from intervention
Postoperative Complications	Evaluation of the incidence of postoperative complications	3 days from intervention
Postoperative Complications	Evaluation of the incidence of postoperative complications	7 days from intervention
Postoperative Complications	Evaluation of the incidence of postoperative complications	30 days from intervention
Evaluation of Quality of Life	Evaluation of the quality of life using a questionnaire	3 days from intervention
Evaluation of Quality of Life	Evaluation of the quality of life using a questionnaire	7 from intervention
Evaluation of Quality of Life	Evaluation of the quality of life using a questionnaire.	30 days from intervention

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):495.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency; Thermoablation; Stockings, Compression; Saphenous Vein
• Other Study ID Numbers: 41/int/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors of the study are the owners of all data collected and will commit to the publication of the data themselves unconditionally and in full.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No