Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Varicose Veins Clinical Trial

Official title:

Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890563
• Other study ID #: 131/2016
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Varicose Veins

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