RCT - Does Treating Incompetent Perforators Reduce Recurrence?

Not Applicable

• Conditions: Varicose Veins
• Interventions: Procedure: EVLA; Procedure: phlebectomies; Procedure: TRansluminal Occlusion of Perforators (TRLOP)

• Registration Number: NCT01949207
• Lead Sponsor: The Whiteley Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19
• Study Start: 2014-07
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVLA, phlebectomies & Trlop closure of incompetent perforators	EVLA	endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
EVLA, phlebectomies & Trlop closure of incompetent perforators	phlebectomies	endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
EVLA, phlebectomies & Trlop closure of incompetent perforators	TRansluminal Occlusion of Perforators (TRLOP)	endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
EVLA & phlebectomies	EVLA	endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.
EVLA & phlebectomies	phlebectomies	endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The Whiteley Clinic; 🇬🇧 Guildford, United Kingdom