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Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

Primary Purpose

Varicose Veins, Venous Insufficiency

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Radiofrequency ablation
High ligation/stripping
Radiofrequency ablation catheter
Tumescent anesthesia
General anesthesia
Vein stripping catheter
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Insufficient great saphenous vein
  • Possible to treat with both radiofrequency ablation and high ligation/stripping
  • Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

Exclusion Criteria:

  • Previous intervention in the affected leg
  • Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
  • Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
  • Patient that is not able to perform plethysmography

Sites / Locations

  • University Hospital Linköping
  • Vrinnevisjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radiofrequency ablation

High ligation/stripping

Arm Description

Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.

Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.

Outcomes

Primary Outcome Measures

Number of treated veins with recanalization using duplex.
Flow detected by duplex at the site of the treated vein.
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Prediction of treatment outcome using plethysmography with superficial shut-down.
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.

Secondary Outcome Measures

VCSS score
The score of standardized examination protocol VCSS.
AVVQ score
The score of disease specific questionnaire AVVQ
EQ-5D score
The score of EQ-5D questionnaire

Full Information

First Posted
March 12, 2015
Last Updated
May 10, 2023
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02397226
Brief Title
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
Official Title
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Venous Insufficiency
Keywords
Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation
Arm Type
Active Comparator
Arm Description
Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
Arm Title
High ligation/stripping
Arm Type
Active Comparator
Arm Description
Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
High ligation/stripping
Other Intervention Name(s)
Open surgery
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation catheter
Other Intervention Name(s)
Covidien ClosureFast Catheter (7cm)
Intervention Type
Procedure
Intervention Name(s)
Tumescent anesthesia
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Type
Device
Intervention Name(s)
Vein stripping catheter
Primary Outcome Measure Information:
Title
Number of treated veins with recanalization using duplex.
Description
Flow detected by duplex at the site of the treated vein.
Time Frame
5 years
Title
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Time Frame
5 years
Title
Prediction of treatment outcome using plethysmography with superficial shut-down.
Description
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
Time Frame
1 month postoperatively
Secondary Outcome Measure Information:
Title
VCSS score
Description
The score of standardized examination protocol VCSS.
Time Frame
5 years
Title
AVVQ score
Description
The score of disease specific questionnaire AVVQ
Time Frame
5 years
Title
EQ-5D score
Description
The score of EQ-5D questionnaire
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Insufficient great saphenous vein Possible to treat with both radiofrequency ablation and high ligation/stripping Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6 Exclusion Criteria: Previous intervention in the affected leg Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein. Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min Patient that is not able to perform plethysmography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Zachrisson, Associate Professor, MD
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oskar Nelzén, MD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Linköping
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Vrinnevisjukhuset
City
Norrköping
State/Province
Östergötland
ZIP/Postal Code
60379
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31959059
Citation
Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20.
Results Reference
derived

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Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

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