RCT - Does Treating Incompetent Perforators Reduce Recurrence?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by The Whiteley Clinic
Sponsor:
Information provided by (Responsible Party):
The Whiteley Clinic
ClinicalTrials.gov Identifier:
NCT01949207
First received: September 19, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Varicose Veins
Procedure: EVLA
Procedure: phlebectomies
Procedure: TRansluminal Occlusion of Perforators (TRLOP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by The Whiteley Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery ] [ Designated as safety issue: No ]
    Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.

  • 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 ] [ Designated as safety issue: No ]
    Patient reported symptom severity - the Aberdeen questionnaire

  • 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 ] [ Designated as safety issue: No ]
    Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    CEAP and VCCS scores


Estimated Enrollment: 190
Study Start Date: July 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949207

Contacts
Contact: Briony Hudson b.f.hudson@surrey.ac.uk

Locations
United Kingdom
The Whiteley Clinic Not yet recruiting
Guildford, United Kingdom, GU2 7RF
Contact: Briony Hudson    01483 477180    b.f.hudson@surrey.ac.uk   
Contact: Isabel Kay    01483 477180    isabel@thewhiteleyclinic.co.uk   
Principal Investigator: Mark S Whiteley, Professor         
Sponsors and Collaborators
The Whiteley Clinic
Investigators
Principal Investigator: Mark S Whiteley, Professor The Whiteley Clinic
  More Information

No publications provided

Responsible Party: The Whiteley Clinic
ClinicalTrials.gov Identifier: NCT01949207     History of Changes
Other Study ID Numbers: RCT20133
Study First Received: September 19, 2013
Last Updated: May 16, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by The Whiteley Clinic:
Incompetent perforating veins
EVLA
Phlebectomies
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

Additional relevant MeSH terms:
Recurrence
Varicose Veins
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014