Back to resultsStaged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Staged ETS
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
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.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Staged ETS
Arm Description
Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728297
Brief Title
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
Official Title
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staged ETS
Arm Type
Experimental
Arm Description
Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side
Intervention Type
Procedure
Intervention Name(s)
Staged ETS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months
Description
decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
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