Varicose VeinsNCT01195623
The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
A study testing preoperative duplex examination and Preoperative duplex in people with Varicose Veins, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- preoperative duplex examination and Preoperative duplex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteSweden
- Study dates
- Nov 1997to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary varicose veins
Who cannot join
- pure cosmetic complaints
- previous venous surgery or sclerotherapy
- history of suspect or manifest deep venous thrombosis
- active or healed venous ulceration
- peripheral arterial disease
- previous significant trauma to the leg
Show all 9Show fewer
- general illness
- alcohol or drug abuse
- unable to understand information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.
- Conditions
- Varicose Veins
- Being tested
- preoperative duplex examination, Preoperative duplex
- Keywords
- varicose veins, venous insufficiency, surgery, duplex, recurrence
- Medical subject headings
- Varicose Veins, Venous Insufficiency, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative duplex examinationProcedure or surgery
Preoperative duplexProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| varicose vein surgery with preop duplex | Active comparator | The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail Receives: Procedure: preoperative duplex examination; Procedure: Preoperative duplex |
| varicose vein surgery no preop duplex | No intervention | The surgeon has planned surgery for varicose veins from a clinical examination only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Re-do Surgery
number of reoperations (legs) in the two treatment arms
Measured: 7 years mean
Secondary outcomes (1)
Recurrence Rate
number of recurrences in treatment arms but also nature of recurrences
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startNov 1997
- Primary completionSep 2003
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capio Research Foundation, Region Stockholm
- Responsible party
- Principal investigator, Lena Blomgren, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195623
- Sponsor's protocol ID
- ETKI 96-169
- Status last verified
- Feb 2013
- First submitted
- 3 Sep 2010
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blomgren L, Johansson G, Bergqvist D. Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial. Ann Vasc Surg. 2006 Jan;20(1):30-4. doi: 10.1007/s10016-005-9285-z.
PubMed 16378147Blomgren L, Johansson G, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Changes in superficial and perforating vein reflux after varicose vein surgery. J Vasc Surg. 2005 Aug;42(2):315-20. doi: 10.1016/j.jvs.2005.03.043.
PubMed 16102633Blomgren L, Johansson G, Bergqvist D. Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery. Br J Surg. 2005 Jun;92(6):688-94. doi: 10.1002/bjs.4983.
PubMed 15810046Blomgren L, Johansson G, Emanuelsson L, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery. Br J Surg. 2011 Aug;98(8):1112-6. doi: 10.1002/bjs.7579. Epub 2011 May 27.
PubMed 21618499Blomgren L. Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):378-382.e1. doi: 10.1016/j.jvsv.2019.11.012. Epub 2020 Jan 25.
PubMed 31992538
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
- ClinicalTrials.gov ID
- NCT01195623
- Acronym / sponsor ID
- ETKI 96-169
- Conditions
- Varicose Veins
- Keywords
- varicose veins, venous insufficiency, surgery, duplex, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Capio Research Foundation, Region Stockholm
- Study start
- Nov 1997
- Primary completion
- Sep 2003 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varicose vein surgery with preop duplex | Active comparator | Procedure: preoperative duplex examination, Procedure: Preoperative duplexThe surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail |
| varicose vein surgery no preop duplex | No intervention | –The surgeon has planned surgery for varicose veins from a clinical examination only |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary varicose veins
Key exclusion criteria (9 listed)
- pure cosmetic complaints
- previous venous surgery or sclerotherapy
- history of suspect or manifest deep venous thrombosis
- active or healed venous ulceration
- peripheral arterial disease
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 |
|---|---|---|
| preoperative duplex examination | Procedure or surgery | varicose vein surgery with preop duplex |
| Preoperative duplex | Procedure or surgery | varicose vein surgery with preop duplex |
Primary outcome
Rate of Re-do Surgery
Time frame: 7 years mean
number of reoperations (legs) in the two treatment arms
1 secondary outcome
Recurrence Rate
Time frame: 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16378147Blomgren L, Johansson G, Bergqvist D. Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial. Ann Vasc Surg. 2006 Jan;20(1):30-4. doi: 10.1007/s10016-005-9285-z.
- Background: PubMed 16102633Blomgren L, Johansson G, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Changes in superficial and perforating vein reflux after varicose vein surgery. J Vasc Surg. 2005 Aug;42(2):315-20. doi: 10.1016/j.jvs.2005.03.043.
- Results publication: PubMed 15810046Blomgren L, Johansson G, Bergqvist D. Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery. Br J Surg. 2005 Jun;92(6):688-94. doi: 10.1002/bjs.4983.
- Results publication: PubMed 21618499Blomgren L, Johansson G, Emanuelsson L, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery. Br J Surg. 2011 Aug;98(8):1112-6. doi: 10.1002/bjs.7579. Epub 2011 May 27.
- Derived from this study: PubMed 31992538Blomgren L. Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):378-382.e1. doi: 10.1016/j.jvsv.2019.11.012. Epub 2020 Jan 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative duplex examination and Preoperative duplex in people with Varicose Veins, run by Uppsala University Hospital at 1 site in Sweden.
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 1 inclusion and 9 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 15 Feb 2013. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Re-do Surgery (time frame: 7 years mean). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195623, which also lists 5 linked publications.
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 15 Feb 2013.