Varicose VeinsNCT02676908
Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery
A study testing Compression socks for 2 weeks in people with Varicose Veins, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
Compression stockings are traditionally worn for a period of time after varicose vein surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation service. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Compression socks for 2 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2016to Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or recurrent varicose veins
- Diagnosis on duplex of truncal (GSV and/or SSV and/or AATV) insufficiency
- Must be able to provide informed consent
Who cannot join
- Patients who require long term compression (active ulcers/ deep venous incompetence)
- Patients who have already had one leg enrolled in the study
- Patients with congenital venous malformations
- Patients who require avulsions only
- Patients who are unable to complete the questionnaires due to a lack of command over the language or who have vision/ hearing disabilities
- Patients who are unable to attend the hospital for follow-up
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St James's Hospital
Dublin, 8
Caitriona Canning, 0860840771, cnichainin@gmail.com
About this study
Official title: A Randomised Controlled Trial Comparing Duration of Compression Hosiery After Endovenous Ablation of Varicose Veins
Compression stockings are traditionally worn for a period of time after varicose vein surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation service. Patients come to the Veins Unit, receive oral sedation, have their veins treated with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic, recover for an hour and then go home. *Phlebectomy describes the technique of pulling out small varicose veins through small incisions in the overlying skin. The standard practice of the Veins Unit is to advise patients to wear class two compression stockings for four weeks post-operatively. Many patients would prefer a shorter period of time in stockings.
The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be worn for after endovenous ablation?'
Read more
Three trials have addressed this issue:
Bakker looked at patients who wore stockings for either two or seven days after laser ablation only; the group who wore stockings for seven days fared better.
Elderman looked at patients who either wore no stockings or stockings for two weeks after laser ablation only; the group who wore stockings for two weeks had less pain.
Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.
None of these trials included patients who had phlebectomies at the same time. This study aims to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group).
Pre-operatively, all patients will fill out a pain score and two short quality of life questionnaires, one specific to varicose veins. Post-operatively at home, all patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at seven days on charts and on a visual scale. At their four week clinic review, all patients will be asked to fill out a pain and bruising score, a bruising chart and the two short quality of life questionnaires again.
The group with the best pain, bruising and quality of life scores post-operatively will help guide duration of compression therapy for future patients.
Read the detailed description
The Nice Guidelines for Varicose Veins, published by the NHS in 2013, questioned the clinical benefit of stockings after endovenous ablation, and if there is benefit, how long the stockings should be worn for.
Three randomised controlled trials have addressed these issues:
Bakker and colleagues randomised 69 patients into two groups- stockings were worn for either two or seven days after laser ablation. The group who wore stockings for seven days had better pain and quality of life scores.
Elderman and colleagues randomised 111 patients who had laser ablation into two groups- a group who wore no stockings, or a group who wore stockings for two weeks. The group who wore stockings for two weeks had less pain and required less analgesia.
Krasznai and colleagues randomised 101 patients into two groups- stockings were worn for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.
None of these trials included patients who had phlebectomies at the same time.
This study hopes to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?'
110 consecutive patients will be randomised into 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group). Randomisation will be facilitated by online random number generation (https://www.random.org/). Patients with odd numbers will be allocated into the trial group; those randomly assigned even numbers will be allocated into the usual treatment group.
Pre-operatively, all patients will be asked to fill out a visual analog pain score (VAS), the Aberdeen Varicose Veins questionnaire and the RAND 36-Item Health Survey. Patients will be evaluated in terms of CAEP staging and the Venous Clinical Severity Score (VCSS) by the supervising nurse or physician.
Endovenous laser therapy (EVLT) plus phlebectomies or radiofrequency ablation (RFA) plus phlebectomies will be performed in the standard manner.
The trial group will wear the stockings for 24 hours a day for the first 4 days, and then during the day only for the next 10 days. The usual treatment group will wear the stockings for 24 hours a day for a week, and then during the day only for the next 3 weeks.
Post-operatively at home, patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at 7 days on a diagram and on a visual analog scale.
At their 4 week clinic review, again the VCSS will completed and patients will be asked to fill out a visual analog pain and bruising score, a bruising diagram, the Aberdeen Varicose Veins questionnaire and the RAND 36-Item Health Survey.
Primary outcome measures are post-operative pain scores on the visual analog scale and post-operative bruising scores on the visual analog scale.
Secondary outcome measures are changes in veins-related quality of life measured on the Aberdeen Varicose Veins Questionnaire and changes in overall quality of life based on the RAND 36-Item Health Survey.
- Conditions
- Varicose Veins
- Being tested
- Compression socks for 2 weeks
- Keywords
- endovenous ablation, laser, radiofrequency, stockings
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression socks for 2 weeksOther
Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks & EVLT | No intervention | After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care) |
| 4 weeks & RFA | No intervention | After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care) |
| 2 weeks & EVLT | Experimental | After endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group) Receives: Other: Compression socks for 2 weeks |
| 2 weeks & RFA | Experimental | After radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group) Receives: Other: Compression socks for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Measured: Change from baseline at four weeks
Secondary outcomes (2)
Quality of Life (Veins Related)
Changes in veins related quality of life based on the Aberdeen Varicose Veins Questionnaire
Measured: Change from baseline at four weeks
Quality of Life (General)
Changes in general quality of life based on the RAND 36-Item Health Survey
Measured: Change from baseline at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitriona Canning, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676908
- Sponsor's protocol ID
- SJH-01-VV
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5.
PubMed 24012465Krasznai AG, Sigterman TA, Troquay S, Houtermans-Auckel JP, Snoeijs M, Rensma HG, Sikkink C, Bouwman LH. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology. 2016 Mar;31(2):118-24. doi: 10.1177/0268355514568658. Epub 2015 Jan 23.
PubMed 25616874
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Duration of Compression Hosiery After Endovenous Ablation of Varicose Veins
- ClinicalTrials.gov ID
- NCT02676908
- Acronym / sponsor ID
- SJH-01-VV
- Conditions
- Varicose Veins
- Keywords
- endovenous ablation, laser, radiofrequency, stockings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 8 Feb 2016 (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.
Compression stockings are traditionally worn for a period of time after varicose vein surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation service. Patients come to the Veins Unit, receive oral sedation, have their veins treated with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic, recover for an hour and then go home. *Phlebectomy describes the technique of pulling out small varicose veins through small incisions in the overlying skin. The standard practice of the Veins Unit is to advise patients to wear class two compression stockings for four weeks post-operatively. Many patients would prefer a shorter period of time in stockings.
The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be worn for after endovenous ablation?'
Three trials have addressed this issue:
Bakker looked at patients who wore stockings for either two or seven days after laser ablation only; the group who wore stockings for seven days fared better.
Elderman looked at patients who either wore no stockings or stockings for two weeks after laser ablation only; the group who wore stockings for two weeks had less pain.
Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.
None of these trials included patients who had phlebectomies at the same time. This study aims to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group).
Pre-operatively, all patients will fill out a pain score and two short quality of life questionnaires, one specific to varicose veins. Post-operatively at home, all patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at seven days on charts and on a visual scale. At their four week clinic review, all patients will be asked to fill out a pain and bruising score, a bruising chart and the two short quality of life questionnaires again.
The group with the best pain, bruising and quality of life scores post-operatively will help guide duration of compression therapy for future patients.
Detailed description
The Nice Guidelines for Varicose Veins, published by the NHS in 2013, questioned the clinical benefit of stockings after endovenous ablation, and if there is benefit, how long the stockings should be worn for.
Three randomised controlled trials have addressed these issues:
Bakker and colleagues randomised 69 patients into two groups- stockings were worn for either two or seven days after laser ablation. The group who wore stockings for seven days had better pain and quality of life scores.
Elderman and colleagues randomised 111 patients who had laser ablation into two groups- a group who wore no stockings, or a group who wore stockings for two weeks. The group who wore stockings for two weeks had less pain and required less analgesia.
Krasznai and colleagues randomised 101 patients into two groups- stockings were worn for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.
None of these trials included patients who had phlebectomies at the same time.
This study hopes to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?'
110 consecutive patients will be randomised into 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group). Randomisation will be facilitated by online random number generation (https://www.random.org/). Patients with odd numbers will be allocated into the trial group; those randomly assigned even numbers will be allocated into the usual treatment group.
Pre-operatively, all patients will be asked to fill out a visual analog pain score (VAS), the Aberdeen Varicose Veins questionnaire and the RAND 36-Item Health Survey. Patients will be evaluated in terms of CAEP staging and the Venous Clinical Severity Score (VCSS) by the supervising nurse or physician.
Endovenous laser therapy (EVLT) plus phlebectomies or radiofrequency ablation (RFA) plus phlebectomies will be performed in the standard manner.
The trial group will wear the stockings for 24 hours a day for the first 4 days, and then during the day only for the next 10 days. The usual treatment group will wear the stockings for 24 hours a day for a week, and then during the day only for the next 3 weeks.
Post-operatively at home, patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at 7 days on a diagram and on a visual analog scale.
At their 4 week clinic review, again the VCSS will completed and patients will be asked to fill out a visual analog pain and bruising score, a bruising diagram, the Aberdeen Varicose Veins questionnaire and the RAND 36-Item Health Survey.
Primary outcome measures are post-operative pain scores on the visual analog scale and post-operative bruising scores on the visual analog scale.
Secondary outcome measures are changes in veins-related quality of life measured on the Aberdeen Varicose Veins Questionnaire and changes in overall quality of life based on the RAND 36-Item Health Survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 weeks & EVLT | No intervention | –After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care) |
| 4 weeks & RFA | No intervention | –After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care) |
| 2 weeks & EVLT | Experimental | Other: Compression socks for 2 weeksAfter endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group) |
| 2 weeks & RFA | Experimental | Other: Compression socks for 2 weeksAfter radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or recurrent varicose veins
- Diagnosis on duplex of truncal (GSV and/or SSV and/or AATV) insufficiency
- Must be able to provide informed consent
Key exclusion criteria (6 listed)
- Patients who require long term compression (active ulcers/ deep venous incompetence)
- Patients who have already had one leg enrolled in the study
- Patients with congenital venous malformations
- Patients who require avulsions only
- Patients who are unable to complete the questionnaires due to a lack of command over the language or who have vision/ hearing disabilities
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 |
|---|---|---|
| Compression socks for 2 weeksPatients in the intervention group will be asked to wear compression stockings for two weeks post-operatively | Other | 2 weeks & EVLT, 2 weeks & RFA |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: Change from baseline at four weeks
2 secondary outcomes
Quality of Life (Veins Related)
Time frame: Change from baseline at four weeks
Quality of Life (General)
Time frame: Change from baseline at four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: PubMed 24012465Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5.
- Background: PubMed 25616874Krasznai AG, Sigterman TA, Troquay S, Houtermans-Auckel JP, Snoeijs M, Rensma HG, Sikkink C, Bouwman LH. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology. 2016 Mar;31(2):118-24. doi: 10.1177/0268355514568658. Epub 2015 Jan 23.
- Elderman JH, Krasznai AG, Voogd AC, Hulsewé KWE, Sikkink CJJM. Role of compression stockings after endovenous laser therapy for primary varicosis. JVS Venous and Lymphatic Disorders. 2014 2(3): 289-296Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression socks for 2 weeks in people with Varicose Veins, run by St. James's Hospital, Ireland at 1 site in Ireland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analog Scale (time frame: Change from baseline at four weeks). 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 NCT02676908, which also lists 2 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 7 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.