Clinical trial NCT06669260: Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins
Official title: Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Varicose Veins
Quality of Life
Laser
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
Collaborators: name: Gabriela de Oliveira Buril
name: Marcelo Halfen Grill
First posted: 2024-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
timeFrame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
timeFrame: Timepoints post-procedire: 1 month, 3 months, 6 months
Secondary outcomes:
measure: Hyperpigmentation
timeFrame: Baseline, 30 days and 180 days
measure: Presence of induration
timeFrame: 30 days and 180 days
measure: Presence of Paresthesia
timeFrame: 30 days and 180 days
measure: Skin burns
timeFrame: 7 days
measure: Lymphedema
timeFrame: 30 days and 180 days
measure: Sclerothrombus
timeFrame: 7 days
measure: Complementary treatment
timeFrame: 180 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Vasconcelos NMCM, Kumakura HS, Grill MH, Silva MCE. Treatment of the small saphenous vein and tributary veins with endolaser associated with ultrasound-guided foam in a patient with post-thrombotic syndrome: presenting the TEThA technique. J Vasc Bras. 2024 Nov 29;23:e20230142. doi: 10.1590/1677-5449.202301422. eCollection 2024.