First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy

NCT06913764 | Completed DMC

• 1 other identifier: 1/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.

Conditions

Varicose Veins; Chronic Venous Disorder; Chronic Venous Insufficiency (CVI); Venous Reflux; Great Saphenous Vein (GSV) With Venous Reflux Disease

Keywords

Varicose veins; Varicose disease; Compression therapy; medical compression stockings; MCS; venous disease; veins; vein surgery; elastic hosiery; compression hosiery; endovenous laser; endovenous laser ablation; thermal ablation; sclerotherapy; microsclerotherapy; phlebectomy; ambulatory phlebectomy; elastic compression

Outcome Measures

Primary Outcomes (1)

• Level of postoperative pain at 14 days

  The intensity of postoperative pain is subjectively assessed by the patient on a 10-centimeter numeric scale daily. The range is from 0 (no pain) to 10 (pain of maximal intensity).

  14 days

Secondary Outcomes (15)

• Area (centimeter square) of ecchymosis

  14 days

• Number of patients with clinical manifestations of phlebitis at 14 days

  14 days

• The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days

  28 days

• VCSS score at 14 days

  14 days

• VCSS score at 28 days

  28 days

Study Arms (2)

Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings

EXPERIMENTAL

All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 1 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.

Device: class I compression stockings of the RAL-GZ 387 standard: 1 month using

Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings

ACTIVE COMPARATOR

All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 2 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.

Device: class II compression stockings of the RAL-GZ 387 standard: 1 month using

Interventions

class I compression stockings of the RAL-GZ 387 standard: 1 month using DEVICE

Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings

Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings

class II compression stockings of the RAL-GZ 387 standard: 1 month using DEVICE

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Varicose veins of the lower extremities (CEAP classification C2-C5)
• Varicose disease in the great saphenous vein (GSV) and its tributaries
• Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries
• Technical success of intervention (complete ablation of the GSV)
• Signed informed consent for study participation

You may not qualify if:

• Primary reflux outside the GSV trunk
• History of or acute deep vein thrombosis
• Deep vein insufficiency
• GSV recanalization post-intervention
• Clinical class C6 of chronic venous disease (CVD) according to CEAP classification
• Contraindications or limitations for prolonged compression therapy, including but not limited to chronic arterial diseases of the lower extremities (any severity), skin diseases
• Pathological conditions of lower limbs causing non-venous pain
• Use of vasoactive medications within 1 month before/after surgery
• Refusal to participate in the study

Sponsors & Collaborators

• Moscow City Hospital named after A.K. Eramishantsev: lead
• Pirogov Russian National Research Medical University: collaborator
• Vishnevsky Center of Surgery: collaborator

Study Sites (1)

Moscow City Hospital named after A.K. Eramishantsev

Moscow, Russia

Location

Related Publications (17)

• Rabe E, Partsch H, Hafner J, Lattimer C, Mosti G, Neumann M, Urbanek T, Huebner M, Gaillard S, Carpentier P. Indications for medical compression stockings in venous and lymphatic disorders: An evidence-based consensus statement. Phlebology. 2018 Apr;33(3):163-184. doi: 10.1177/0268355516689631. Epub 2017 Feb 22.

  PMID: 28549402 BACKGROUND

• Ma F, Xu H, Zhang J, Premaratne S, Gao H, Guo X, Yang T. Compression Therapy Following Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Ann Vasc Surg. 2022 Mar;80:302-312. doi: 10.1016/j.avsg.2021.09.035. Epub 2021 Nov 11.

  PMID: 34774690 BACKGROUND

• Hu H, Wang J, Wu Z, Liu Y, Ma Y, Zhao J. No Benefit of Wearing Compression Stockings after Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):103-111. doi: 10.1016/j.ejvs.2021.09.034. Epub 2021 Nov 11.

  PMID: 34776296 BACKGROUND

• Reich-Schupke S, Murmann F, Altmeyer P, Stucker M. Quality of life and patients' view of compression therapy. Int Angiol. 2009 Oct;28(5):385-93.

  PMID: 19935593 BACKGROUND

• Kankam HKN, Lim CS, Fiorentino F, Davies AH, Gohel MS. A Summation Analysis of Compliance and Complications of Compression Hosiery for Patients with Chronic Venous Disease or Post-thrombotic Syndrome. Eur J Vasc Endovasc Surg. 2018 Mar;55(3):406-416. doi: 10.1016/j.ejvs.2017.11.025. Epub 2018 Jan 9.

  PMID: 29329662 BACKGROUND

• Ayala A, Guerra JD, Ulloa JH, Kabnick L. Compliance with compression therapy in primary chronic venous disease: Results from a tropical country. Phlebology. 2019 May;34(4):272-277. doi: 10.1177/0268355518798153. Epub 2018 Sep 6.

  PMID: 30189813 BACKGROUND

• Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014.

  PMID: 17980798 BACKGROUND

• Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018 Jun;37(3):181-254. doi: 10.23736/S0392-9590.18.03999-8. No abstract available.

  PMID: 29871479 BACKGROUND

• Gianesini S, Obi A, Onida S, Baccellieri D, Bissacco D, Borsuk D, Campisi C, Campisi CC, Cavezzi A, Chi YW, Chunga J, Corda D, Crippa A, Davies A, De Maeseneer M, Diaz J, Ferreira J, Gasparis A, Intriago E, Jawien A, Jindal R, Kabnick L, Latorre A, Lee BB, Liew NC, Lurie F, Meissner M, Menegatti E, Molteni M, Morrison N, Mosti G, Narayanan S, Pannier F, Parsi K, Partsch H, Rabe E, Raffetto J, Raymond-Martimbeau P, Rockson S, Rosukhovski D, Santiago FR, Schul A, Schul M, Shaydakov E, Sibilla MG, Tessari L, Tomaselli F, Urbanek T, van Rijn MJ, Wakefield T, Wittens C, Zamboni P, Bottini O. Global guidelines trends and controversies in lower limb venous and lymphatic disease: Narrative literature revision and experts' opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23-25 January 2019. Phlebology. 2019 Sep;34(1 Suppl):4-66. doi: 10.1177/0268355519870690. No abstract available.

  PMID: 31495256 BACKGROUND

• Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002.

  PMID: 30554745 BACKGROUND

• Kolluri R, Hays KU, Gohel MS. Foam Sclerotherapy Augmented Phlebectomy (SAP) Procedure for Varicose Veins: Report of a Novel Technique. EJVES Short Rep. 2018 Nov 16;41:16-18. doi: 10.1016/j.ejvssr.2018.10.007. eCollection 2018.

  PMID: 30519649 BACKGROUND

• Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.

  PMID: 19283745 BACKGROUND

• De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.

  PMID: 35027279 BACKGROUND

• Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101670. doi: 10.1016/j.jvsv.2023.08.011. Epub 2023 Aug 29.

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  BACKGROUND

• Luebke T, Brunkwall J. Systematic review and meta-analysis of endovenous radiofrequency obliteration, endovenous laser therapy, and foam sclerotherapy for primary varicosis. J Cardiovasc Surg (Torino). 2008 Apr;49(2):213-33.

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• Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101.

  PMID: 18278775 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hovsep P. Manjikian, MD

  Moscow City Hospital named after A.K. Eramishantsev

  STUDY CHAIR

• Boris Danelian, MD

  Moscow City Hospital named after A.K. Eramishantsev

  PRINCIPAL INVESTIGATOR

• Hovsep Manjikyan, MD

  Moscow City Hospital named after A.K. Eramishantsev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single-center, open, non-inferiority randomized controlled trial with a blinded outcome assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A single-center, open, non-inferiority randomized controlled trial with a blinded outcome assessor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 7, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 2, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)