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Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Primary Purpose

Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Class II Compression Stockings
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation

Eligibility Criteria

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

Inclusion Criteria:

  • Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation

Exclusion Criteria:

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Patient unwilling to participate

Sites / Locations

  • Raahe's hospital
  • Oulu University Hospital, Vascular Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No Compression

Compression

Arm Description

Patients in this group will not receive any compression after treatment.

Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).

Outcomes

Primary Outcome Measures

Truncal vein occlusion rate

Secondary Outcome Measures

Post-operative pain assessed with visual analogue scale (VAS)
Painkillers usage after treatment
Need for Paracetamol/NSAIDs after treatment
Aberdeen Varicose Veins Questionnaire (AVVQ)
Assessed preoperatively and at one and six months
Compliance with compression stockings
To assess compliance and possible reasons for non-compliance at compression group
Time required returning to normal work and activity level
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).

Full Information

First Posted
August 31, 2016
Last Updated
March 29, 2019
Sponsor
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02890563
Brief Title
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Official Title
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
Detailed Description
In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group. Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage. Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
No Compression
Arm Type
No Intervention
Arm Description
Patients in this group will not receive any compression after treatment.
Arm Title
Compression
Arm Type
Active Comparator
Arm Description
Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
Intervention Type
Device
Intervention Name(s)
Class II Compression Stockings
Primary Outcome Measure Information:
Title
Truncal vein occlusion rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post-operative pain assessed with visual analogue scale (VAS)
Time Frame
10 days
Title
Painkillers usage after treatment
Description
Need for Paracetamol/NSAIDs after treatment
Time Frame
10 days
Title
Aberdeen Varicose Veins Questionnaire (AVVQ)
Description
Assessed preoperatively and at one and six months
Time Frame
6 months
Title
Compliance with compression stockings
Description
To assess compliance and possible reasons for non-compliance at compression group
Time Frame
7 days
Title
Time required returning to normal work and activity level
Time Frame
14 days
Title
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
Description
Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more) Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4 Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation Exclusion Criteria: History of pulmonary embolism or deep venous thrombosis Large (>12mm) truncal vein diameter CEAP C5-C6 Patient unwilling to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Pihlaja, M.D.
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raahe's hospital
City
Raahe
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
92101
Country
Finland
Facility Name
Oulu University Hospital, Vascular Department
City
Oulu
ZIP/Postal Code
90220
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31753745
Citation
Pihlaja T, Romsi P, Ohtonen P, Jounila J, Pokela M. Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):73-80. doi: 10.1016/j.ejvs.2019.08.020. Epub 2019 Nov 18.
Results Reference
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Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

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