RCT - Does Treating Incompetent Perforators Reduce Recurrence?

May 16, 2014 updated by: The Whiteley Clinic

Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.

The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

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

  • United Kingdom
      • Guildford, United Kingdom, GU2 7RF
        • The Whiteley Clinic

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 varicose veins caused by great saphenous vein reflux
  • At least one incompetent perforating vein refluxing into the varicosities
  • Over 18 years of age

Exclusion Criteria:

  • Reflux from pelvic vein origin or small saphenous vein
  • Previous varicose vein surgery,
  • Incompetent perforators remote from the varicosities treated,
  • Deep vein incompetence
  • Deep vein obstruction or occlusion

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVLA, phlebectomies & Trlop closure of incompetent perforators
endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Procedure: EVLA
Endovenous laser ablation of great saphenous vein
Procedure: phlebectomies
removal of incompetent veins
Procedure: TRansluminal Occlusion of Perforators (TRLOP)
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Experimental: EVLA & phlebectomies
endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.
Procedure: EVLA
Endovenous laser ablation of great saphenous vein
Procedure: phlebectomies
removal of incompetent veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in the level of significant recurrence between the two treatment pathways
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

Differences in the level of significant recurrence between the two treatment pathways at each follow up.

Significant recurrence would be indicated if the participant demonstrates varicose veins greater than 3mm in diameter, varicose veins associated with thrombophlebitis or skin changes such as venous eczema, red skin or brown skin overlying the veins which require further treatment.
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in insignificant recurrence between the two treatment pathways
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported symptom severity
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported symptom severity - the Aberdeen questionnaire
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported quality of life
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient satisfaction with treatment.
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Clinician reported severity of symptoms
Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
CEAP and VCCS scores
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

Collaborators and Investigators

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

Sponsor

The Whiteley Clinic

Investigators

  • Principal Investigator: Mark S Whiteley, Professor, The Whiteley Clinic

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

July 1, 2014

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT20133

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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