Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728297
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Tracking Information
First Submitted Date  ICMJE March 27, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months [ Time Frame: 24 months ]
decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
Official Title  ICMJE Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE Procedure: Staged ETS
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.
Study Arms  ICMJE Experimental: Staged ETS
Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side
Intervention: Procedure: Staged ETS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728297
Other Study ID Numbers  ICMJE mansoura32
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sameh Emile, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh H Emile, M.D Mansoura University
PRS Account Mansoura University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP