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Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890563
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Toni Pihlaja, Oulu University Hospital

Study Description
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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)

Condition or disease Intervention/treatment Phase
Varicose Veins Device: Class II Compression Stockings Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Study Start Date : August 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Compression
Patients in this group will not receive any compression after treatment.
Active Comparator: Compression
Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
 Device: Class II Compression Stockings


Outcome Measures
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Primary Outcome Measures :
  1. Truncal vein occlusion rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Post-operative pain assessed with visual analogue scale (VAS) [ Time Frame: 10 days ]
  2. Painkillers usage after treatment [ Time Frame: 10 days ]
    Need for Paracetamol/NSAIDs after treatment

  3. Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: 6 months ]
    Assessed preoperatively and at one and six months

  4. Compliance with compression stockings [ Time Frame: 7 days ]
    To assess compliance and possible reasons for non-compliance at compression group

  5. Time required returning to normal work and activity level [ Time Frame: 14 days ]
  6. Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively [ Time Frame: 30days ]
    Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890563


Locations
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Finland
Raahe's hospital
Raahe, Pohjois-Pohjanmaa, Finland, 92101
Oulu University Hospital, Vascular Department
Oulu, Finland, 90220
Sponsors and Collaborators
Oulu University Hospital
Investigators
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Principal Investigator: Toni Pihlaja, M.D. Oulu University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Toni Pihlaja, M.D., Oulu University Hospital
ClinicalTrials.gov Identifier: NCT02890563    
Other Study ID Numbers: 131/2016
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Keywords provided by Toni Pihlaja, Oulu University Hospital:
Varicose veins
Compression stockings
Sclerotherapy
Radiofrequency ablation
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases