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OpenTrials
Completed

NCT Number: NCT03840655

Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The team from thoracic department of Peking University People's Hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People'S Hospital

Beijing, Beijing Municipality, +86-010, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with primary palmar hyperhydrosis.
  • Accept surgical treatment and signed informed consent.

Exclusion criteria

  • Liver dysfunction.
  • Allergic to indocyanine green.
  • Can't tolerate thoracoscopic surgery.

Treatment and study plan

Near-Infrared Imaging Thoracoscopy

Procedure

Sympathicotomy performed by near-infrared imaging thoracoscopy

Primary outcomes

  1. Anatomical variation of the sympathetic ganglions

    Time frame: during surgery

    Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.

Secondary outcomes

  1. Improvement of palmar sweating

    Time frame: 1 month after surgery

    Use questionnaire including 3 descriptive names of scale ( over dry, comfortable and wet) to record the surgical effect on palmar sweating.

  2. Degree of compensatory hyperhidrosis

    Time frame: 1 month after surgery

    Use questionnaire including 4 descriptive names of scale ( none, mild, moderate and severe) to record the side effect (compensatory hyperhidrosis) of this surgery.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Beijing Municipal Science & Technology Commission

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

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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