Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

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

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

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Procedure: Staged ETS

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: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Sameh H Emile, M.D, Mansoura University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: mansoura32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO