Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

Completed

• Conditions: Palmar Hyperhidrosis
• Interventions: Procedure: Near-Infrared Imaging Thoracoscopy

• Registration Number: NCT03840655
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-16
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
palmar hyperhidrosis	Near-Infrared Imaging Thoracoscopy	VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions.

Primary Outcome Measures

Name	Time	Method
Anatomical variation of the sympathetic ganglions	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

Name	Time	Method
Degree of compensatory hyperhidrosis	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.
Improvement of palmar sweating	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.

Trial Locations

Locations (1)

Peking University People'S Hospital; 🇨🇳 Beijing, Beijing, China