NCT01949207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

5.2 years

First QC Date

September 19, 2013

Last Update Submit

May 16, 2014

Conditions

Varicose Veins

Keywords

Incompetent perforating veinsEVLAPhlebectomiesTRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

Secondary Outcomes (5)

  • Differences in insignificant recurrence between the two treatment pathways

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

  • Patient reported symptom severity

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

  • Patient reported quality of life

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

  • Patient satisfaction with treatment.

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

  • Clinician reported severity of symptoms

    Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery

Study Arms (2)

EVLA, phlebectomies & Trlop closure of incompetent perforators

EXPERIMENTAL

endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

Procedure: EVLAProcedure: phlebectomiesProcedure: TRansluminal Occlusion of Perforators (TRLOP)

EVLA & phlebectomies

EXPERIMENTAL

endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.

Procedure: EVLAProcedure: phlebectomies

Interventions

EVLAPROCEDURE

Endovenous laser ablation of great saphenous vein

EVLA & phlebectomiesEVLA, phlebectomies & Trlop closure of incompetent perforators
phlebectomiesPROCEDURE

removal of incompetent veins

EVLA & phlebectomiesEVLA, phlebectomies & Trlop closure of incompetent perforators
TRansluminal Occlusion of Perforators (TRLOP)PROCEDURE

TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

EVLA, phlebectomies & Trlop closure of incompetent perforators

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mark S Whiteley, Professor

    The Whiteley Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Briony Hudson

CONTACT

b.f.hudson@surrey.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

July 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

GB(1)