Thoracoscopic Sympathectomy for Blushing | NCT00225069

Studies
Thoracoscopic Sympathectomy for Blushing

NCT00225069

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Aug 23, 2012Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Facial Blushing

Interventions

Level of sympathectomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2012

Last Update Posted Date

Aug 23, 2012Estimated

Name	Class
Aarhus University Hospital	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	T2 sympathectomy	Procedure: Level of sympathectomy
2	Experimental	T2-T3 sympathectomy	Procedure: Level of sympathectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Level of sympathectomy	Procedure	T2 sympathectomy or T2-T3 sympathectomy	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of operation. Side effects: compensatory and gustatory sweating.		12 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter B Licht, MD PhD	Odense University Hospital	Principal Investigator
Hans K Pilegaard, MD	Skejby Sygehus, Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital		Aarhus		8200	Denmark
Dept Cardiothorcic Surgery, Odense University Hospital