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Clinical Trials/NCT00225069
NCT00225069CompletedPhase 4

Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.

Odense University Hospital2 sites in 1 country100 target enrollmentStarted: September 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Effect of operation. Side effects: compensatory and gustatory sweating.

Study Overview

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.

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

T2 sympathectomy

Intervention: Level of sympathectomy (Procedure)

2

Experimental

T2-T3 sympathectomy

Intervention: Level of sympathectomy (Procedure)

Outcomes

Primary Outcomes

Effect of operation. Side effects: compensatory and gustatory sweating.

Time Frame: 12 months after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter B Licht

Professor

Odense University Hospital

Study Sites (2)

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