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Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

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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

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Procedure: Staged ETS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study
Study Start Date : January 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Staged ETS
Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728297


Locations
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Egypt
Mansoura university hospital
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh H Emile, M.D Mansoura University

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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02728297     History of Changes
Other Study ID Numbers: mansoura32
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases