Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins (TEThA)

Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment

Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Varicose Veins; Laser
• Intervention / Treatment: Procedure: TEThA technique

Detailed Description

Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Eduardo Ramacciotti, MD, PhD; Phone Number: +55 11 4040-8670; Email: eduardoramacciotti@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP

Description

Inclusion Criteria:

Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6

Exclusion Criteria:

Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TEThA technique

Procedure: TEThA technique; Patient in an orthostatic position, previously marked varicose veins will be punctured with a tracing adjacent to them, surrounding their edges. Applying an augmented reality device and Doppler ultrasound (Doppler USG), the marking will be complemented in the supine position. These punctures will in turn be carried out using the TEThA technique - endovenous thermoablation of tributary veins by means of transfixation - and will be done sequentially as they are treated one by one with endo- and perivenous thermoablation under generous tumescence with 0.08% lidocaine in saline solution. The laser used to treat the tributary veins will also be 1470 nm and will be fired as the fiber is removed at a speed of 1 mm/sec and power ranging from 5 to 7 watts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)	AVVQ is an easy-to-administer, self-administered instrument, it consists of 3 dimensions, which are physical, sociofunctional and psychological. It is interpreted through a score, which can vary between 0 and 100, with 0 representing no evidence of varicose veins and 100 the most serious problem associated with varicose veins.	Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.	Timepoints post-procedire: 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperpigmentation	Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)	Baseline, 30 days and 180 days
Presence of induration	Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)	30 days and 180 days
Presence of Paresthesia	Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique	30 days and 180 days
Skin burns	Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique	7 days
Lymphedema	Presence or absence of lymphedema diagnosed by exam of lymphoscintigraphy in the limb treated by endovenous laser TEThA technique	30 days and 180 days
Sclerothrombus	Presence of Sclerothrombus (US doppler)	7 days
Complementary treatment	Percentage of participants with residual veins	180 days

Collaborators and Investigators

• Sponsor: Nara Medeiros Cunha de Melo Vasconcelos
• Collaborators: Gabriela de Oliveira Buril; Marcelo Halfen Grill

Publications and helpful links

General Publications

• Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27. Erratum In: J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):288. doi: 10.1016/j.jvsv.2020.11.002.
• 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. Erratum In: Eur J Vasc Endovasc Surg. 2022 Aug-Sep;64(2-3):284-285. doi: 10.1016/j.ejvs.2022.05.044.
• Salim S, Machin M, Patterson BO, Onida S, Davies AH. Global Epidemiology of Chronic Venous Disease: A Systematic Review With Pooled Prevalence Analysis. Ann Surg. 2021 Dec 1;274(6):971-976. doi: 10.1097/SLA.0000000000004631.
• Nara MCMV, Marcelo HG, et al. Treatment of small saphenous vein and tributary veins with endolaser associated with ultrasound-guided foam in a patient with post-thrombotic syndrome: presenting the TEThA technique. Brazilian Vascular Journal [Proof] 2023.

Study record dates

Study Major Dates

• Study Start (Estimated): November 21, 2024
• Primary Completion (Estimated): July 22, 2025
• Study Completion (Estimated): July 22, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins
• Other Study ID Numbers: TEThA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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