Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery

September 6, 2018 updated by: Caitriona Canning, St. James's Hospital, Ireland

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?'

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 8
        • Recruiting
        • St James's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 4 weeks & EVLT
After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care)
No Intervention: 4 weeks & RFA
After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care)
Experimental: 2 weeks & EVLT
After endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group)
Other: Compression socks for 2 weeks
Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively
Experimental: 2 weeks & RFA
After radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group)
Other: Compression socks for 2 weeks
Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: Change from baseline at four weeks
Change from baseline at four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (Veins Related)
Time Frame: Change from baseline at four weeks
Changes in veins related quality of life based on the Aberdeen Varicose Veins Questionnaire
Change from baseline at four weeks
Quality of Life (General)
Time Frame: Change from baseline at four weeks
Changes in general quality of life based on the RAND 36-Item Health Survey
Change from baseline at four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. James's Hospital, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJH-01-VV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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