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Thoracoscopic Sympathectomy for Blushing

NCT ID: NCT00225069

Last Updated: 2012-08-23

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2012-01-31

Brief Summary

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To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.

Detailed Description

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To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery

Conditions

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Facial Blushing

Keywords

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Facial blushing Sympathectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

T2 sympathectomy

Group Type EXPERIMENTAL

Level of sympathectomy

Intervention Type PROCEDURE

T2 sympathectomy or T2-T3 sympathectomy

2

T2-T3 sympathectomy

Group Type EXPERIMENTAL

Level of sympathectomy

Intervention Type PROCEDURE

T2 sympathectomy or T2-T3 sympathectomy

Interventions

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Level of sympathectomy

T2 sympathectomy or T2-T3 sympathectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Isolated disabling facial blushing
* Over 18 years of age
* Willing to be randomized

Exclusion Criteria

* Primary hyperhidrosis in palms or axillae
* Previous lung surgery
* Bradycardia
* Arrythmias
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter B Licht

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter B Licht, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Hans K Pilegaard, MD

Role: STUDY_CHAIR

Skejby Sygehus, Aarhus University Hospital

Locations

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Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Dept Cardiothorcic Surgery, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TOPSY1-2005

Identifier Type: -

Identifier Source: org_study_id