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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890563
Other study ID # 131/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date March 2019

Study information

Verified date March 2019
Source Oulu University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Class II Compression Stockings


Locations

Country Name City State
Finland Oulu University Hospital, Vascular Department Oulu
Finland Raahe's hospital Raahe Pohjois-Pohjanmaa

Sponsors (1)

Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Truncal vein occlusion rate 6 months
Secondary Post-operative pain assessed with visual analogue scale (VAS) 10 days
Secondary Painkillers usage after treatment Need for Paracetamol/NSAIDs after treatment 10 days
Secondary Aberdeen Varicose Veins Questionnaire (AVVQ) Assessed preoperatively and at one and six months 6 months
Secondary Compliance with compression stockings To assess compliance and possible reasons for non-compliance at compression group 7 days
Secondary Time required returning to normal work and activity level 14 days
Secondary 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). 30days
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