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Trial record 10 of 173 for:    "Sweat Gland Disease"

Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT03840655
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Palmar Hyperhidrosis Procedure: Near-Infrared Imaging Thoracoscopy

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Group/Cohort Intervention/treatment
palmar hyperhidrosis
VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions.
Procedure: Near-Infrared Imaging Thoracoscopy
Sympathicotomy performed by near-infrared imaging thoracoscopy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients suffering from primary palmar hyperhidrosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Liver dysfunction.
  2. Allergic to indocyanine green.
  3. Can't tolerate thoracoscopic surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840655


Locations
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China, Beijing
Peking University People'S Hospital
Beijing, Beijing, China, +86-010
Sponsors and Collaborators
Peking University People's Hospital
Beijing Municipal Science & Technology Commission

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Responsible Party: Jun Wang, Department Chief, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03840655     History of Changes
Other Study ID Numbers: 2017PHB101-01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases