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Thoracoscopic Sympathectomy for Blushing

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Peter B Licht, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00225069
First received: September 21, 2005
Last updated: August 22, 2012
Last verified: August 2012
  Purpose
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 Intervention Phase
Facial Blushing Procedure: Level of sympathectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.

Further study details as provided by Peter B Licht, Odense University Hospital:

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

Enrollment: 100
Study Start Date: September 2005
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225069

Locations
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
Principal Investigator: Peter B Licht, MD PhD Odense University Hospital, Denmark
Study Chair: Hans K Pilegaard, MD Skejby Sygehus, Aarhus University Hospital
  More Information

Responsible Party: Peter B Licht, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00225069     History of Changes
Other Study ID Numbers: TOPSY1-2005
Study First Received: September 21, 2005
Last Updated: August 22, 2012

Keywords provided by Peter B Licht, Odense University Hospital:
Facial blushing
Sympathectomy

ClinicalTrials.gov processed this record on June 26, 2017