Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

• ClinicalTrials.gov Identifier: NCT02890563
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Last Update Posted: April 1, 2019
• Sponsor: Oulu University Hospital
• Information provided by (Responsible Party): Toni Pihlaja, Oulu University Hospital

Tracking Information

• First Submitted Date: August 31, 2016
• First Posted Date: September 7, 2016
• Last Update Posted Date: April 1, 2019
• Study Start Date: August 2016
• Actual Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2016): Truncal vein occlusion rate [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Varicose Veins
• Intervention: Device: Class II Compression Stockings

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 31, 2016): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2019
• Actual Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT02890563
• Other Study ID Numbers: 131/2016
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Toni Pihlaja, Oulu University Hospital
• Study Sponsor: Oulu University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Toni Pihlaja, M.D.; Oulu University Hospital

• PRS Account: Oulu University Hospital
• Verification Date: March 2019