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Completed

NCT Number: NCT02728297

Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

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

Completed

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Staged ETS

Procedure

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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