COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
Primary Purpose
Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Class 2 compression stockings
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Foam sclerotherapy, Compression
Eligibility Criteria
Inclusion Criteria:
- Adults over 18 years of age
- Varicose veins suitable for foam sclerotherapy
Exclusion Criteria:
- Allergic to sclerosant
- Current DVT
- Arterial disease (ABPI<0.8)
- Patients unable to wear compression stockings
- Patients who are unwilling to participate
- Inability or unwillingness to complete questionnaires
- Inability to attend follow-up appointments
Sites / Locations
- Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Compression stockings
No compression
Arm Description
Patients randomised to group A will be asked to wear compression stockings for 1 week
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards
Outcomes
Primary Outcome Measures
Patient's pain score post-procedure using a visual analogue scale (VAS)
Pain score
Secondary Outcome Measures
Aberdeen Varicose Vein Questionnaire (AVVQ) score
Disease-specific quality of life score
Chronic venous insufficiency (CIVIQ) score
Disease-specific quality of life score
EuroQol's EQ-5D
Generic quality of life score
Venous clinical severity score (VCSS)
Clinical
Occlusion rate
Occlusion rates will be assessed based on a pre-agreed scale
Degree of phlebitis
Extent of phlebitis will be recorded using a scale
Full Information
NCT ID
NCT02655406
First Posted
January 12, 2016
Last Updated
August 4, 2022
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02655406
Brief Title
COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins
Acronym
CONFETTI
Official Title
COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
August 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Detailed Description
This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). This will be done by using an online randomisation software (Sealed Envelope Ltd).
The compression therapy used will be Class II compression stockings. The treatment offered will be foam sclerotherapy of varicose veins using either Polidocanol or Sodium Tetradecyl Sulphate (STS) with the concentration used left to the discretion of the clinician.
Patients randomised to group A will be asked to wear compression stockings for 1 week.
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards.
At baseline, patients will be asked to fill validated quality of life questionnaires (EQ-5D, AVVQ and CIVIQ) and will have their clinical scores assessed using a validated scoring system (CEAP and VCSS). On discharge after their varicose vein intervention, they will then be provided with a diary to record their post-procedural pain every day for 10 days using a validated visual analogue scale (VAS) as well as to record when they return to their normal activities and are back to work. They will also be asked to attend a follow-up in 2 weeks and at 6 months.
Patients' GP will also be sent a letter to inform them of their patient's participation in the study.
Follow-up
Patients will be followed up in the outpatient clinic at 2 weeks and 6 months.
Follow-up at 2 Weeks
At the 2 weeks' follow-up, the diary containing details of the pain scores and how soon patients were able to return to normal activities/work will be collected. In addition, patients will be asked about any phlebitis they have had in the two weeks after their procedure and how compliant they have been with the compression. They will be examined and the Venous Clinical Severity Score (VCSS) will be recorded. They will also be asked to fill in the EQ-5D, AVVQ and CIVIQ scores.
Follow-up at 6 Months
At the 6 months follow-up, patients will be examined and their VCSS will be recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. They will have a venous Duplex scan to determine occlusion of the treated vein.
Sample Size and Study Duration
We estimated the sample size needed to observe a difference of at least 10mm in the VAS score, with a standard deviation of 20mm. With power at 80% and 5% significance equivalence, we would need to recruit 128 patients (64 per group) to show a difference.
Previous studies looking at compression stockings have shown drop out rates close to 37% at 3 months10. Therefore, if we estimate a drop out rate of about 40% by 6 months, we would need to recruit at least 180 patients. If we recruit at least 2 patients per week, this will be approximately a total of 208 patients that could potentially be randomised over the course of two years.
With 6 months follow-up, therefore, the study will be running for 24 months with a target recruitment of 180 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Foam sclerotherapy, Compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression stockings
Arm Type
Active Comparator
Arm Description
Patients randomised to group A will be asked to wear compression stockings for 1 week
Arm Title
No compression
Arm Type
No Intervention
Arm Description
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards
Intervention Type
Other
Intervention Name(s)
Class 2 compression stockings
Primary Outcome Measure Information:
Title
Patient's pain score post-procedure using a visual analogue scale (VAS)
Description
Pain score
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Aberdeen Varicose Vein Questionnaire (AVVQ) score
Description
Disease-specific quality of life score
Time Frame
6 months
Title
Chronic venous insufficiency (CIVIQ) score
Description
Disease-specific quality of life score
Time Frame
6 months
Title
EuroQol's EQ-5D
Description
Generic quality of life score
Time Frame
6 months
Title
Venous clinical severity score (VCSS)
Description
Clinical
Time Frame
6 months
Title
Occlusion rate
Description
Occlusion rates will be assessed based on a pre-agreed scale
Time Frame
6 months
Title
Degree of phlebitis
Description
Extent of phlebitis will be recorded using a scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults over 18 years of age
Varicose veins suitable for foam sclerotherapy
Exclusion Criteria:
Allergic to sclerosant
Current DVT
Arterial disease (ABPI<0.8)
Patients unable to wear compression stockings
Patients who are unwilling to participate
Inability or unwillingness to complete questionnaires
Inability to attend follow-up appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan Bootun
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins
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