Clinical trial NCT01701661: Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Official title: Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: venous surgery
compression therapy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 153
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 compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.

Detailed description: Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.

Eligibility criteria: Inclusion Criteria:

* patients with chronic superficial vein insufficiency
* patient must be 20-70 years old
* degree of difficulty of vein insufficiency C2-C3
* venous disability score 1-2
* patient is agreeable to the study

Exclusion Criteria:

* peripheral atherosclerotic occlusive disease
* lymphoedema
* severe concomitant disease (ASA 3-5)
* venous ulcers or unclassified skin changes
* BMI more than 35

Primary outcomes:
measure: Symptom relief
timeFrame: two years
Secondary outcomes:
measure: Quality of life
timeFrame: two years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Vascular Surgery, Helsinki University Central Hospital
state: HUS
Study officials:
affiliation: Department of Vascular Surgery, Helsinki University Central Hospital
name: Maarit Venermo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: