Back to resultsRCT - Does Treating Incompetent Perforators Reduce Recurrence?
Primary Purpose
Varicose Veins
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EVLA
phlebectomies
TRansluminal Occlusion of Perforators (TRLOP)
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Eligibility Criteria
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
Sites / Locations
- The Whiteley Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EVLA, phlebectomies & Trlop closure of incompetent perforators
EVLA & phlebectomies
Arm Description
endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.
Outcomes
Primary Outcome Measures
Differences in the level of significant recurrence between the two treatment pathways
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.
Secondary Outcome Measures
Differences in insignificant recurrence between the two treatment pathways
Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.
Patient reported symptom severity
Patient reported symptom severity - the Aberdeen questionnaire
Patient reported quality of life
Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)
Patient satisfaction with treatment.
Clinician reported severity of symptoms
CEAP and VCCS scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01949207
Brief Title
RCT - Does Treating Incompetent Perforators Reduce Recurrence?
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Whiteley Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EVLA, phlebectomies & Trlop closure of incompetent perforators
Arm Type
Experimental
Arm Description
endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Arm Title
EVLA & phlebectomies
Arm Type
Experimental
Arm Description
endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.
Intervention Type
Procedure
Intervention Name(s)
EVLA
Intervention Description
Endovenous laser ablation of great saphenous vein
Intervention Type
Procedure
Intervention Name(s)
phlebectomies
Intervention Description
removal of incompetent veins
Intervention Type
Procedure
Intervention Name(s)
TRansluminal Occlusion of Perforators (TRLOP)
Intervention Description
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Primary Outcome Measure Information:
Title
Differences in the level of significant recurrence between the two treatment pathways
Description
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.
Time Frame
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Secondary Outcome Measure Information:
Title
Differences in insignificant recurrence between the two treatment pathways
Description
Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.
Time Frame
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Title
Patient reported symptom severity
Description
Patient reported symptom severity - the Aberdeen questionnaire
Time Frame
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Title
Patient reported quality of life
Description
Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time Frame
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Title
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
Title
Clinician reported severity of symptoms
Description
CEAP and VCCS scores
Time Frame
Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Briony Hudson
Email
b.f.hudson@surrey.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Whiteley, Professor
Organizational Affiliation
The Whiteley Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Whiteley Clinic
City
Guildford
ZIP/Postal Code
GU2 7RF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Briony Hudson
Phone
01483 477180
Email
b.f.hudson@surrey.ac.uk
First Name & Middle Initial & Last Name & Degree
Isabel Kay
Phone
01483 477180
Email
isabel@thewhiteleyclinic.co.uk
First Name & Middle Initial & Last Name & Degree
Mark S Whiteley, Professor
12. IPD Sharing Statement
Learn more about this trial
RCT - Does Treating Incompetent Perforators Reduce Recurrence?
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