Compression And Functional Ability After Endovenous Varicose Vein Treatment

NCT ID: NCT03613376

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2021-01-01

Brief Summary

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Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)

Detailed Description

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Conditions

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Varicose Veins of Lower Limb Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Compression

Patients in this group will not receive any compression after treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Compression

Patients in this group will use class II compression stockings continuously until next evening and then next 4 days during daytime.

Group Type ACTIVE_COMPARATOR

Class II compression stockings

Intervention Type OTHER

Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime

Interventions

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Class II compression stockings

Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
* Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
* Distal varicose vein insufficiency suitable for sclerotherapy
* Patient willingness to participate

Exclusion Criteria

* History of pulmonary embolism or deep venous thrombosis
* Large (\>12mm) truncal vein diameter
* CEAP C5-C6
* Antithrombotic medication (ASA accepted)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Toni Pihlaja

Vascular specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu University Hospital, Vascular Department

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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97/2018

Identifier Type: -

Identifier Source: org_study_id

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