Varicose Veins Clinical Trial
Official title:
A Randomised Controlled Trial Investigating The Use Of Pelvic Vein Embolisation To Reduce Recurrent Varicose Veins Of The Legs In Women With Recurrent Varicose Veins And Associated Pelvic Venous Reflux.
The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic embolisation) in females with recurrent leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence after endovenous laser treatment for recurrent varicose veins in the legs.
Status | Not yet recruiting |
Enrollment | 270 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Females presenting with recurrent varicose veins in one or both legs with ultrasound proven pelvic venous reflux in at least one pelvic venous trunk communicating with the leg varicose veins - Duplex proven reflux in the superficial venous system of the leg - Over 18 years old - Able to understand and give consent - Willing to attend for follow-up over the five years Exclusion Criteria: - Pelvic venous reflux does not communicate with the varicose veins to be treated in the legs - If pelvic venous reflux communicates and contributes to varicose veins in one leg but not the other, only the leg with a pelvic venous contribution will be entered into the study - Currently pregnant or plans for pregnancy within the next five years - Under 18 years of age - Unable to understand all give consent - Any vascular malformation of the pelvis all the legs apart from that diagnosed as venous reflux disease - Any medical condition likely to cause death or serious ill-health within the next five years Any deep venous obstruction or reflux |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Imaging Clinic | Guildford | |
United Kingdom | The Whiteley Clinic | Guildford |
Lead Sponsor | Collaborator |
---|---|
The Whiteley Clinic |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Incidences of thrombophlebitis and deep vein thrombosis. | 6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery | No |
Primary | Change in recurrent varicose veins or venus reflux | Does the patient have recurrence? Recurrent varicose veins will be divided into: Clinically insignificant (thread veins, reticular veins or varicose veins less than 3 mm in diameter) Significant (varicose veins greater than 3 mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as venous eczema, red skin or Brown skin overlying the veins) |
6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post surgery | No |
Secondary | Quality of life | Participants will complete the Chronic Venous Insufficiency Questionnaire (CIVIQ) The CIVIQ comprises 20 questions in four quality-of-life domains: physical, psychological, social, and pain. |
6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery | No |
Secondary | Patient satisfaction | Participants will complete a visual analogue scale, from 0 (completely dissatisfied) to 10 (completely satisfied) to indicate their level of satisfaction with the treatment that they have received. | 6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery | No |
Secondary | Symptom severity | Participants will complete the Aberdeen questionnaire to assess the severity and impact of their varicose veins on their lives. Duplex ultrasound, the CEAP and VCCS will also be used to assess the severity of symptoms. |
6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery | No |
Secondary | Source of recurrence | Duplex ultrasound will be used to identify the source of any recurrent varicose veins, enabling classification into: recurrence due to pelvic venous incompetence recurrence of leg varicose veins due to failure of surgery recurrence of leg varicose veins due to de novo reflux |
6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery | No |
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