Clinical trial NCT01722019: Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
Official title: Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency C2 or Higher
Keywords: venous insufficiency
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: European Venous Forum.
name: Benelux Society of Phlebology.
First posted: 2012-11-06
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,...


Eligibility criteria: Inclusion Criteria:

* Endovenous ablation of the great saphenous vein (GSV) planned
* Patient signed informed consent
* Patient must complete the 1 year follow-up
* CEAP between 2 and 6
* BMI=\<35
* Diameter of the GSV in upward position less than 20 mm diameter
* No problems in deep venous system

Exclusion Criteria:

* No informed consent is signed
* Latex allergy
* Arterial insufficiency
* Deep vein thrombosis or deep vein insufficiency
* Klippel Trenaunay
* Diameter fo GSV \> 20 mm
* Cross dilation with 2 or more insufficient side branches
* Previous GSV operation
* Redo-operation
* Carcinoma less than 1 year ago
* BMI \> 35
* Liver-insufficiency with contraindication for local tumescence
* Intake of warfarins
* Pregnancy, breastfeeding, \< 3 months after pregnancy
* Bilateral GSV insufficiency that has to be treated
* Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV

Primary outcomes:
measure: Closure of the greater saphenous vein at 12 months.
timeFrame: 12 months after procedure
Secondary outcomes:
measure: Pain.
timeFrame: after 5 days
measure: Pain.
timeFrame: after 14 days
measure: Pain.
timeFrame: after 1 month
measure: Pain.
timeFrame: after 6 months
measure: Pain.
timeFrame: after 1 year.
measure: Patient satisfaction rate.
timeFrame: after 5 days
measure: Patient satisfaction rate.
timeFrame: After 14 days.
measure: Patient satisfaction rate.
timeFrame: After 1 month
measure: Pain satisfaction rate.
timeFrame: After 6 months
measure: Patient satisfaction rate.
timeFrame: After 1 year.
measure: Incapacity to work.
timeFrame: after 5 days
measure: Incapacity to work.
timeFrame: After 14 days
measure: Incapacity to work.
timeFrame: After 1 month
measure: Incapacity to work.
timeFrame: After 6 months
measure: Incapacity to work.
timeFrame: After 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Tielt
country: Belgium
facility: Sint-Andriesziekenhuis Tielt
Study officials:
affiliation: University Hospital, Ghent
name: Carend Randon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: