RCT - Does Treating Incompetent Perforators Reduce Recurrence?

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01949207

Enrollment

190

Registered

2013-09-24

Start date

2014-07-31

Completion date

2019-09-30

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

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.

Interventions

PROCEDUREEVLA

Endovenous laser ablation of great saphenous vein

PROCEDUREphlebectomies

removal of incompetent veins

PROCEDURETRansluminal Occlusion of Perforators (TRLOP)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Differences in the level of significant 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	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

Measure	Time frame	Description
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	Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.
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 symptom severity - the Aberdeen questionnaire
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 reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)
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	CEAP and VCCS scores

Countries

United Kingdom

Contacts

Primary ContactBriony Hudson

b.f.hudson@surrey.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026