Clinical trial NCT01972633: Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Official title: Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Venous Insufficiency
Keywords: endovenous treatment
Laser, Vnus Closure Fast
Varicosis
great saphenous vein
small saphenous vein
Venous Insufficiency
Lead sponsor: Ludwig Boltzmann Institute for Operative Laparoscopy
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

Detailed description: The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.

In this study there are no additional risk factors for the included study patients except the risk of surgery.

Eligibility criteria: Inclusion Criteria:

* varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
* maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm

Exclusion Criteria:

* surgical treatment of the saphenous vein in the past
* sclerotherapy of the saphenous vein in the past
* phlebitis or thrombosis of the saphenous vein
* surgical treatment of an venous ulcer in the past
* postthrombotic syndrome
* erysipelas of the leg in the past
* chronic treatment with pain-killers or chronic alcoholism
* pregnancy
* drug allergy against painkillers that are used in this study
* spinal anesthesia not possible
* compression bandage not possible
* patients with polyneuropathy
* patients with chronic pain
* persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
* participation on an other clinical trial that can interfere with this clinical trial
* missing written informed consent

Primary outcomes:
measure: Pain
timeFrame: day 0
Secondary outcomes:
measure: Obliteration of the treated vein (GSV or SSV)
timeFrame: day 10, month 3, month 12
measure: Patient´s satisfaction after the intervention
timeFrame: day 10, month 3, month 12
Other outcomes:
measure: paresthesia of the lower leg after intervention
timeFrame: day 10, month 3, month 12
Locations:
city: Linz
country: Austria
facility: 2.Chirurgische Abteilung AKh Linz GesmbH
state: Oberösterreich
Study officials:
affiliation: 2.Chirurgische Abteilung AKh Linz GesmbH
name: Markus Schreiner
role: PRINCIPAL_INVESTIGATOR
affiliation: 2. Chirurgische Abteilung AKh Linz GesmbH
name: Andreas Shamiyeh
role: STUDY_CHAIR
References: