Clinical trial NCT04231942: Elastic Compression Stockings and Varicose Veins Recurrence
Official title: Elastic Compression Stockings in the Prevention of Varicose Veins Recurrence After Endovenous Thermal Ablation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Varicose Veins
Chronic Venous Insufficiency
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, open, superiority randomized clinical trial with blinded outcome assessor.
Primary purpose: TREATMENT

Brief summary: Hypothesis. Regular using of Class 1 below-knee graduated compression stockings (RAL GZ 387 standard) compared to the absence of elastic compression will reduce the risk of clinically significant varicose veins recurrence at 12 months after endovenous thermal ablation of the great saphenous vein and elimination of varicose tributaries.

Detailed description: The incidence of new varicose veins (VVs) appearance at 3 years after any invasive treatment is about 20%, and the progression rate of chronic venous disease (CVD) at 2 years after the endovenous thermal ablation (ETA) reaches 40%. When comparing open surgery and endovenous laser ablation (EVLA), the frequency of VVs recurrence at 12 months after intervention does not significantly differ and amounts to 10%. A previous study examining the effect of elastic compression on the risk of VVs recurrence after surgery showed a 92% reduction in relative risk. However, it was limited to the low number of followed patients and the absence of the compliance measurement. Thus, there is still no evidence, if long term using of graduated compression stockings (GSV) after modern modalities of VVs treatment (ETA with mini/micro phlebectomy or sclerotherapy) provides any benefits in the reduction of VVs recurrence. Also, there is no information on what regimen for GCS using is effective to reduce the risk of VVs recurrence: continuous use at every day or intermittent using only during specific activities.

Our hypothesis is that regular using of Class 1 below-knee graduated compression stockings (RAL GZ 387 standard) compared to the absence of elastic compression will reduce the risk of clinically significant varicose veins recurrence at 12 months after endovenous thermal ablation of the great saphenous vein and elimination of varicose tributaries.

The aim of the study is to assess the efficacy of regular using of below-knee graduated compression stockings (GCS) of Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) on the risk of varicose veins clinical recurrence after endovenous thermal obliteration of the great saphenous vein and eliminating varicose tributaries in patients without residual varicose veins and / or venous symptoms.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years;
* Varicose veins (VVs) in the system of great saphenous vein (GSV) of one lower limb;
* Performed endovenous thermal ablation (ETA) of the GSV trunk - endovenous laser ablation (EVLA) or radiofrequency ablation (RFA) - and elimination of varicose tributaries by mini (micro) phlebectomy or sclerotherapy during the 30-45 days before enrollment;
* The technical success of the performed ETA, the absence of reflux in the GSV trunk and the absence of residual VVs;
* Lack of signs of chronic venous disease (CVD): clinical class of C0-1 according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification;
* Lack of vein-specific symptoms - the intensity of any validated vein-specific symptom is less than 30% according to the numeric rating scale (NRS);
* Signed informed consent.

Exclusion Criteria:

* Bilateral VVs;
* Primary reflux outside the GSV trunk (including combined);
* History of deep or superficial veins thrombosis;
* Verified deep vein reflux;
* Verified non-thrombotic or post-thrombotic venous obstruction;
* Verified pelvic venous insufficiency;
* Persistence of superficial reflux after ETA;
* A tendency for recanalization of previously obliterated veins;
* Persistence of residual VVs - clinical class of C2 by CEAP;
* Persistence of signs of CVD - clinical class of C3 and higher by CEAP;
* Persistence of one or more vein-specific symptom with an intensity of 30% and higher by NRS;
* The need for long-term use of elastic compression;
* Contraindications or restrictions for the long-term use of GCS;
* The need for long-term use of vein-active drugs (more than 1 month);
* Refusal to participate in the study.

Primary outcomes:
measure: Number of patients with clinical recurrence of varicose veins on any lower limb
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with clinical recurrence of varicose veins on treated limb
timeFrame: 12 months
measure: Number of patients with ultrasound recurrence of varicose veins on any lower limb
timeFrame: 12 months
measure: Number of patients with ultrasound recurrence of varicose veins on treated limb
timeFrame: 12 months
measure: Number of patients with recanalization of obliterated great saphenous vein
timeFrame: 12 months
measure: Number of patients underwent re-intervention for VVs
timeFrame: 12 months
measure: Number of patients with C0-C1 clinical classes of СVD by CEAP classification
timeFrame: 12 months
measure: The value of VCSS on the treated limb
timeFrame: 12 months
measure: The value of CIVIQ-20 score
timeFrame: 12 months
measure: Compliance with the use of GCS
timeFrame: 12 months
measure: Comfort with GCS
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital name by A.K. Yeramishantsev
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital no.24
city: Moscow
country: Russian Federation
facility: Moscow private medical clinic "MedSwiss"
Study officials:
affiliation: Pirogov RNRMU
name: Leonid Laberko, PhD
role: STUDY_CHAIR
affiliation: Pirogov RNRMU
name: Leonid Laberko, PhD
role: PRINCIPAL_INVESTIGATOR
References: