Venous InsufficiencyNCT01701661
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
A study testing Operative treatment and conservative treatment in people with Venous Insufficiency, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Operative treatment and conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2004to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- peripheral atherosclerotic occlusive disease
- lymphoedema
- severe concomitant disease (ASA 3-5)
- venous ulcers or unclassified skin changes
- BMI more than 35
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, 00029
About this study
Official title: Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Venous Insufficiency
- Being tested
- Operative treatment, conservative treatment
- Keywords
- venous surgery, compression therapy
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatmentProcedure or surgery
stripping of main trunk or if previously removed, removal or ligating the refluating trunk
conservative treatmentOther
Compression stockings class II
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Active comparator | Compression stockings class II Receives: Other: conservative treatment |
| Operative treatment | Active comparator | stripping of main trunk or if previously removed, removal or ligating the refloating trunk Receives: Procedure: Operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (1)
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).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2004
- Primary completionOct 2008
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Maarit Venermo, MD,PhD, Principal investigator, Department of Vascular Surgery, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701661
- Sponsor's protocol ID
- TYH4209
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01701661
- Acronym / sponsor ID
- TYH4209
- Conditions
- Venous Insufficiency
- Keywords
- venous surgery, compression therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | Active comparator | Other: conservative treatmentCompression stockings class II |
| Operative treatment | Active comparator | Procedure: Operative treatmentstripping of main trunk or if previously removed, removal or ligating the refloating trunk |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- peripheral atherosclerotic occlusive disease
- lymphoedema
- severe concomitant disease (ASA 3-5)
- venous ulcers or unclassified skin changes
- BMI more than 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operative treatmentstripping of main trunk or if previously removed, removal or ligating the refluating trunk | Procedure or surgery | Operative treatment |
| conservative treatmentCompression stockings class II | Other | conservative treatment |
Primary outcome
Symptom relief
Time frame: two years
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.
1 secondary outcome
Quality of life
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarit Venermo, MD,PhD principal investigator
Department of Vascular Surgery, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative treatment and conservative treatment in people with Venous Insufficiency, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom relief (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.