Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728297
• Other study ID #: mansoura32
• Status: Completed
• Phase: N/A
• First received: March 27, 2016
• Last updated: April 4, 2016
• Start date: January 2010
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No