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Thoracoscopic Sympathectomy for Blushing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225069
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : August 23, 2012
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Peter B Licht, Odense University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Blushing Procedure: Level of sympathectomy Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.
Study Start Date : September 2005
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: 1
T2 sympathectomy
Procedure: Level of sympathectomy
T2 sympathectomy or T2-T3 sympathectomy

Experimental: 2
T2-T3 sympathectomy
Procedure: Level of sympathectomy
T2 sympathectomy or T2-T3 sympathectomy




Primary Outcome Measures :
  1. Effect of operation. Side effects: compensatory and gustatory sweating. [ Time Frame: 12 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225069


Locations
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Denmark
Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, Denmark, 8200
Dept Cardiothorcic Surgery, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Investigators
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Principal Investigator: Peter B Licht, MD PhD Odense University Hospital, Denmark
Study Chair: Hans K Pilegaard, MD Skejby Sygehus, Aarhus University Hospital

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Responsible Party: Peter B Licht, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00225069    
Other Study ID Numbers: TOPSY1-2005
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012
Keywords provided by Peter B Licht, Odense University Hospital:
Facial blushing
Sympathectomy