Clinical trial NCT01298908: Comparison of Treatments in Venous Insufficiency
Official title: The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: varicose veins, oedema
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 231
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.

Detailed description: In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Eligibility criteria: Inclusion Criteria:

* patients with chronic superficial vein insufficiency
* patient must be 20-70 years old
* degree of difficulty of vein insufficiency C2-C4
* average diameter of refluxing great saphenous vein 4 -10 mm
* patient is agreeable to the study

Exclusion Criteria:

* peripheral atherosclerotic occlusive disease
* lymphoedema
* severe concomitant disease
* venous ulcers or unclassified skin changes
* BMI more than 40
* pregnancy
* allergy to the foam used in sclerotherapy or to local anaesthetics
* coagulation disorder
* bilateral vein insufficiency (equal symptoms)

Primary outcomes:
measure: Recanalization or reflux of the treated venous trunk
timeFrame: at 1 and 12 months
Secondary outcomes:
measure: Symptom relief
timeFrame: at 1 and 12 months
measure: Complications related to procedure
timeFrame: at 1 and 12 months
measure: Quality of life
timeFrame: at 1 and 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Vascular Surgery, Helsinki University Central Hospital
state: HUS
city: Tampere
country: Finland
facility: Department of Vascular Surgery, Tampere University Hospital
Study officials:
affiliation: Department of Vascular Surgery, Helsinki University Central Hospital
name: Maarit Venermo, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757.