RCT - Does Treating Incompetent Perforators Reduce Recurrence?

Varicose Veins Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01949207
• Other study ID #: RCT20133
• Status: Not yet recruiting
• Phase: N/A
• First received: September 19, 2013
• Last updated: May 16, 2014
• Start date: July 2014
• Est. completion date: September 2019

Study information

• Verified date: May 2014
• Source: The Whiteley Clinic
• Contact: Briony Hudson
• Email: b.f.hudson[@]surrey.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• EVLA
Endovenous laser ablation of great saphenous vein
• phlebectomies
removal of incompetent veins
• TRansluminal Occlusion of Perforators (TRLOP)
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

Locations

Country	Name	City	State
United Kingdom	The Whiteley Clinic	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
The Whiteley Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery	No
Secondary	Patient reported symptom severity	Patient reported symptom severity - the Aberdeen questionnaire	Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery	No
Secondary	Patient reported quality of life	Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)	Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery	No
Secondary	Patient satisfaction with treatment.		Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery	No
Secondary	Clinician reported severity of symptoms	CEAP and VCCS scores	Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery	No