Thoracoscopic Sympathectomy for Blushing

Facial Blushing Clinical Trial

Official title:

Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225069
• Other study ID #: TOPSY1-2005
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: August 22, 2012
• Start date: September 2005
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Blushing

Intervention

Procedure:
• Level of sympathectomy
T2 sympathectomy or T2-T3 sympathectomy

Locations

Country	Name	City	State
Denmark	Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital	Aarhus
Denmark	Dept Cardiothorcic Surgery, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of operation. Side effects: compensatory and gustatory sweating.		12 months after surgery	No