Staged Extended Thoracoscopic Sympathicotomy for Palmo-ax... | NCT02728297

Studies
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

NCT02728297

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Apr 5, 2016Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Hyperhidrosis

Interventions

Staged ETS

Countries

Egypt

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

Mar 2016

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

Jan 2010

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 27, 2016

First Submission Date that Met QC Criteria

Apr 4, 2016

First Posted Date

Apr 5, 2016Estimated

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

Apr 4, 2016

Last Update Posted Date

Apr 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Detailed Description

This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Staged ETS	Experimental	Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side	Procedure: Staged ETS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Staged ETS	Procedure	Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months	decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

Exclusion Criteria:

Patients under 16 years.
Patients with bradycardia (heart rate <80 beats per minute).
Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
Patients with cardiac problems with ejection fraction less than 60%.
Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis.
Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameh H Emile, M.D	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006945	Hyperhidrosis

Ancestor Terms

ID	Term
D013543	Sweat Gland Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided