NCT05372146

Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

86 patients were randomized into hot-CHIVA (n=43) and control (n=43) groups. Study group patients had undergone radiofrequency ablation (RFA) VNUS Closure - FastTM of one segment of GSV close to saphenofemoral junction. Controls had undergone whole refluxing trunk ablation. Additional phlebectomy was performed in all the patients of both groups. Primary end-point was change in quality of life (QoL) measured with CIVIQ-20 at 12 months. Secondary end-points was recurrence of varicose veins at 12 months. The investigators also measured GSV caliber at the median and distal thigh change in hot-CHIVA group.

Detailed description

Aim - to compare GSV segmental radiofrequency ablation (hot-CHIVA) and conventional GSV ablation in varicose veins patients. This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins. In a study group (hot-CHIVA) GSV segmental ablation with concomitant phlebectomy was performed. Conventional GSV radiofrequency ablation was performed in a control group. Patients were enrolled from November, 2019 to February, 2021. All patients were examined clinically. Age, height, weight, body mass index, gender, side of disease, personal history of varicose veins were recorded. Medical history was taken. Disease description was made using advanced CEAP classification. Quality of life was measured by CIVIQ-20 and leg discomfort related to CVD symptoms on the operated leg was measured with a 10-cm visual analogue scale (VAS). Duplex ultrasound was performed in a standing position to access deep veins and GSV. We recorded reflux extention and presence of the re-entry perforators on the thigh or upper calf. Diameter of GSV near SFJ, at the middle, and lower part of the thigh was measured at inclusion in the both groups. Sample size The sample size was calculated considering the average values for the CIVIQ-20 quality of life questionnaire on 2nd year after the endovascular treatment and CHIVA treatment obtained by reviewing the literature. Selected parameters: first-order error (α) 5%; power 80%; boundaries of "non-inferiority limit" 2; the expected difference between the study groups of 0. Taking into account the possible dropout of patients from the study, the size of the groups is increased by 5%. The estimated sample size is 86 participants. Statistical analysis Data are presented using descriptive statistics. Normally distributed data are presented as mean with standard deviation. Not normally distributed data are presented as (Me) and interquartile range (Q1 - Q3). Two independent groups were compared with Student's t-test or Mann-Whitney test depending on data distribution. Friedman test was used to compare dependent variables. Pearson's chi-squared test or Fisher's exact test were used to compare nominal variables. A p-value of \<0.05 was considered statistically significant.

Conditions

• Varicose Veins
• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
PROCEDURE	GSV radiofrequency ablation with concomitant phlebectomy	Radiofrequency ablation with concomitant phlebectomy

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-09-01
• Completion: 2022-02-27
• First posted: 2022-05-12
• Last updated: 2022-05-19

Locations

1 site across 1 country: Russia