Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Operative treatment
conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring venous surgery, compression therapy
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
Sites / Locations
- Department of Vascular Surgery, Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conservative treatment
Operative treatment
Arm Description
Compression stockings class II
stripping of main trunk or if previously removed, removal or ligating the refloating trunk
Outcomes
Primary Outcome Measures
Symptom relief
Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.
Secondary Outcome Measures
Quality of life
Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).
Full Information
NCT ID
NCT01701661
First Posted
October 3, 2012
Last Updated
October 4, 2012
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01701661
Brief Title
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
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
venous surgery, compression therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conservative treatment
Arm Type
Active Comparator
Arm Description
Compression stockings class II
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
stripping of main trunk or if previously removed, removal or ligating the refloating trunk
Intervention Type
Procedure
Intervention Name(s)
Operative treatment
Intervention Description
stripping of main trunk or if previously removed, removal or ligating the refluating trunk
Intervention Type
Other
Intervention Name(s)
conservative treatment
Intervention Description
Compression stockings class II
Primary Outcome Measure Information:
Title
Symptom relief
Description
Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarit Venermo, MD,PhD
Organizational Affiliation
Department of Vascular Surgery, Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular Surgery, Helsinki University Central Hospital
City
Helsinki
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
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