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Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery

Primary Purpose

Varicose Veins

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Compression socks for 2 weeks
Sponsored by
St. James's Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Varicose Veins focused on measuring endovenous ablation, laser, radiofrequency, stockings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • St James's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

4 weeks & EVLT

4 weeks & RFA

2 weeks & EVLT

2 weeks & RFA

Arm Description

After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care)

After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care)

After endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group)

After radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group)

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analog Scale

Secondary Outcome Measures

Quality of Life (Veins Related)
Changes in veins related quality of life based on the Aberdeen Varicose Veins Questionnaire
Quality of Life (General)
Changes in general quality of life based on the RAND 36-Item Health Survey

Full Information

First Posted
August 6, 2015
Last Updated
September 6, 2018
Sponsor
St. James's Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02676908
Brief Title
Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery
Official Title
A Randomised Controlled Trial Comparing Duration of Compression Hosiery After Endovenous Ablation of Varicose Veins
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. James's Hospital, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
endovenous ablation, laser, radiofrequency, stockings

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 weeks & EVLT
Arm Type
No Intervention
Arm Description
After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care)
Arm Title
4 weeks & RFA
Arm Type
No Intervention
Arm Description
After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care)
Arm Title
2 weeks & EVLT
Arm Type
Experimental
Arm Description
After endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group)
Arm Title
2 weeks & RFA
Arm Type
Experimental
Arm Description
After radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group)
Intervention Type
Other
Intervention Name(s)
Compression socks for 2 weeks
Intervention Description
Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
Change from baseline at four weeks
Secondary Outcome Measure Information:
Title
Quality of Life (Veins Related)
Description
Changes in veins related quality of life based on the Aberdeen Varicose Veins Questionnaire
Time Frame
Change from baseline at four weeks
Title
Quality of Life (General)
Description
Changes in general quality of life based on the RAND 36-Item Health Survey
Time Frame
Change from baseline at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitriona Canning
Phone
0860840771
Email
cnichainin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24012465
Citation
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.
Results Reference
background
PubMed Identifier
25616874
Citation
Krasznai 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.
Results Reference
background
Links:
URL
http://dx.doi.org/10.1016/j.jvsv.2014.01.003
Description
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): 289-296

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Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery

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