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PREservation Versus Thermal Ablation (PRETA)

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ClinicalTrials.gov Identifier: NCT04034329
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ihar Ihnatovich, Belarusian State Medical University

Brief Summary:
This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

Condition or disease Intervention/treatment
Varicose Veins Procedure: ASVAL Procedure: EVLA

Detailed Description:

Full venous duplex ultrasonography was performed using Medical ultrasound scan. Cognizant of the negative consequences of standing and sitting for long periods of time (e.g. venous hypertension, venous reflux), we scheduled investigations for early morning, thus ensuring examination of the physiological status of the venous system in each patient. Ultrasound examinations of reflux at the saphenofemoral junction (SFJ) were performed using the Valsalva maneuver. Ultrasound examination of GSV reflux was performed by manually compressing the calf followed by sudden release. Reverse flow that lasted more than 0.5 seconds was considered pathological. Preoperative venous duplex mapping was done in the upright position. Further measurements of the GSV diameter 15 cm below the SFJ level were conducted to describe the severity of varicose veins more accurately.

The diameter of GSV at the 15-cm below the SFJ level was the main criterion to identify two groups of patients. Those with the GSV diameter ≤ 6 mm were treated with ASVAL. If the diameter of GSV was > 6 mm, EVLA with concomitant phlebectomy was performed.

All surgical procedures were accomplished by the same surgeon, using tumescent local anesthesia (i.e. 0,1% lidocaine and sodium bicarbonate solution without epinephrine).The EVLA was done under duplex guidance with a 1560-nm diode laser using bare fibres via a Seldinger wire technique. The GSV was cannulated at the lowest point of the reflux. The laser fiber was advanced below the SFJ at the level of v. epigastrica sup. after which the GSV was ablated during gradual withdrawal of the fibre. The 15 Watts laser power was delivered in a continuous pull back traction. The average applied linear endovenous energy dose (LEED) was 75,3 J/cm.

Peripheral side branches were removed by multiple stab avulsions in both groups. After the treatment, the leg was wrapped in sterile absorbent bandages, and compression stockings class II (23-32 mm Hg) were put on and recommended to wear for two weeks. All patients were discharged on the day of the treatment and were invited to a follow-up duplex ultrasonography (DUS) on the 1st post-operative day, 2 years and 5 years after the operation (patients were contacted by phone). DUS at follow-up visits was carried out by an independent specialist who was not involved in the initial treatment of the patients. To report clinical recurrence after EVLA we have used Group d' Evaluation des Lasers et de l'Echographie Vasculare (GELEV) score.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: PREservation Versus Thermal Ablation of the Incompetent Great Saphenous Vein in Varicose Veins Treatment
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : July 23, 2019
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Group/Cohort Intervention/treatment
ASVAL - group
GSV diameter ≤ 6 mm
Procedure: ASVAL
Ambulatory Selective Varices Ablation under Local Anesthesia

EVLA-group
GSV diameter > 6 mm
Procedure: EVLA
Endovenous Laser Ablation




Primary Outcome Measures :
  1. Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3) [ Time Frame: 2-5 years ]
    None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)

  2. Number of Participants with varicose Veins from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)

  3. Number of Participants with venous oedema from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)

  4. Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)

  5. Number of Participants with inflammation from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)

  6. Number of Participants with induration from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)

  7. Number of Participants with active ulcers from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), 1 (1), 2 (2), more than 2 (3)

  8. Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)

  9. Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)

  10. Number of Participants with compression therapy from absent (score 0) to severe (score 3). [ Time Frame: 2-5 years ]
    Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)


Secondary Outcome Measures :
  1. Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1) [ Time Frame: 2-5 years ]
    Visible or palpable varicosity with a diameter of less than 3 mm after surgery (0). Visible or palpable varicosity with a diameter of more than 3 mm after surgery (1).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria
Criteria

Inclusion Criteria:

  • Great saphenous vein (GSV) incompetence with reflux at least down to the knee level
  • Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C3
  • Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations)

Exclusion Criteria:

  • Previous surgical groin exploration, except herniotomy
  • Small saphenous vein, anterior or posterior accessory saphenous vein incompetence at the same limb
  • Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome
  • Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034329


Contacts
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Contact: Ihar Ihnatovich, MD, Prof +375447811210 iniini67@gmail.com

Locations
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Belarus
Educational Institution"Belarusian State Medical University" Recruiting
Minsk, Dzerzhinski Ave., 83, Belarus, 220116
Contact: Genadz Kandratsenka, Prof    +375173400454    surg1@bsmu.by   
Sponsors and Collaborators
Belarusian State Medical University
Investigators
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Study Chair: Genadz Kandratsenka, Prof Educational Institution"Belarusian State Medical University"
Publications:

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Responsible Party: Ihar Ihnatovich, Professor, Belarusian State Medical University
ClinicalTrials.gov Identifier: NCT04034329    
Other Study ID Numbers: 20140451
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 01.2020
Access Criteria: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ihar Ihnatovich, Belarusian State Medical University:
ASVAL
EVLA
GSV
Long-term efficacy
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases