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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

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date April 1, 2019
Study Start Date  ICMJE August 2016
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Truncal vein occlusion rate [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
  • Post-operative pain assessed with visual analogue scale (VAS) [ Time Frame: 10 days ]
  • Painkillers usage after treatment [ Time Frame: 10 days ]
    Need for Paracetamol/NSAIDs after treatment
  • Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: 6 months ]
    Assessed preoperatively and at one and six months
  • Compliance with compression stockings [ Time Frame: 7 days ]
    To assess compliance and possible reasons for non-compliance at compression group
  • Time required returning to normal work and activity level [ Time Frame: 14 days ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
  • Post-operative pain assessed with visual analogue scale (VAS) [ Time Frame: 10 days ]
  • Painkillers usage after treatment [ Time Frame: 10 days ]
    Need for Paracetamol/NSAIDs after treatment
  • Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: 6 months ]
    Assessed preoperatively and at one and six months
  • Compliance with compression stockings [ Time Frame: 7 days ]
    To assess compliance and possible reasons for non-compliance at compression group
  • Time required returning to normal work and activity level [ Time Frame: 14 days ]
  • 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 neccessary (Patient is instructed to contact outpatient clinic in case of problems).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Official Title  ICMJE Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Varicose Veins
Intervention  ICMJE Device: Class II Compression Stockings
Study Arms  ICMJE
  • 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).
    Intervention: Device: Class II Compression Stockings
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02890563
Other Study ID Numbers  ICMJE 131/2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toni Pihlaja, Oulu University Hospital
Study Sponsor  ICMJE Oulu University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toni Pihlaja, M.D. Oulu University Hospital
PRS Account Oulu University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP