Clinical trial NCT03856814: Market Penetration of Laser Therapy in Venous Surgery: Ziekenhuis Oost-Limburg - Ziekenhuis Maas En Kempen Center Experience
Official title: Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients with varicose veins, indicative for treatment with Endovenous laser ablation (EVLA) or Surgery (ligation/stripping) according to routine patient care.

Brief summary: The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).


Eligibility criteria: Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).

Exclusion Criteria:

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Pregnancy.
4. Coagulopathy or bleeding disorders.
5. Contraindications to the use of general or regional anesthesia.

Primary outcomes:
measure: To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
timeFrame: At baseline
measure: To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
timeFrame: At 6 weeks follow-up
Secondary outcomes:
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Procedural characteristics
timeFrame: At index-procedure
measure: Pain scoring using the Visual Analog Scale (VAS)
timeFrame: At discharge, up to 1 week
measure: Pain scoring using the Visual Analog Scale (VAS)
timeFrame: At 6 weeks follow-up
measure: Anatomic success of EndoVenous Laser Ablation (EVLA)
timeFrame: At 6 weeks follow-up
measure: Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: At baseline
measure: Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: At 6 weeks follow-up
measure: Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: At 6 months follow-up
measure: Post-operative adverse events
timeFrame: At discharge, up to 1 week
measure: Post-operative adverse events
timeFrame: At 6 weeks follow-up
measure: Post-operative adverse events
timeFrame: At 6 months follow-up
measure: Re-interventions
timeFrame: At discharge, up to 1 week
measure: Re-interventions
timeFrame: At 6 weeks follow-up
measure: Re-interventions
timeFrame: At 6 months follow-up
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (Sint-Jan,Genk; Sint-Barbara,Lanaken; ZMK,Maaseik)
state: Limburg
Study officials:
References: