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Clinical Trials/NCT02728297
NCT02728297CompletedNot Applicable

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

Mansoura University1 site in 1 country42 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Staged ETS

Experimental

Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side

Intervention: Staged ETS (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sameh Emile

Lecturer of general surgery

Mansoura University

Study Sites (1)

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