An observational study in Varicose Veins, sponsored by Belarusian State Medical University. Active, not recruiting at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Belarusian State Medical University · Observational
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).
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.
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's planned enrollment of 300 is above the median of 159 across 62 observational studies indexed under Varicose Veins.
Browse Varicose Veins studies →Belarusian State Medical University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GSV diameter ≤ 6 mm
Procedure: ASVAL
GSV diameter \> 6 mm
Procedure: EVLA
Ambulatory Selective Varices Ablation under Local Anesthesia
Endovenous Laser Ablation
Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)
Time frame: 5-10 years
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Time frame: 5-10 years
Number of Participants with venous oedema from absent (score 0) to severe (score 3).
None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
Time frame: 5-10 years
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Time frame: 5-10 years
Number of Participants with inflammation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Time frame: 5-10 years
Number of Participants with zone of induration from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Time frame: 5-10 years
Number of Participants with number of active ulcers from absent (score 0) to severe (score 3).
None (0), 1 (1), 2 (2), more than 2 (3)
Time frame: 5-10 years
Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3).
None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
Time frame: 5-10 years
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Time frame: 5-10 years
Number of Participants with compression therapy from absent (score 0) to severe (score 3).
Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)
Time frame: 5-10 years
Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1)
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).
Time frame: 5-10 years
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Belarusian State Medical University