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Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

NCT02733497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-12

No results posted yet for this study

Summary

Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory to medical treatment .

The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but anatomic studies have showed that "accessory" fibers from the T2 and T3 sympathetic ganglia come to the heart and influence its function.

Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a shift of sympathovagal balance toward parasympathetic tone but remains unclear if these changes are associated with the extend of ETS.

Thus, in the present study the investigator performed a prospective analysis of HRV function in patients with EPH undergoing different sympathetic denervations as sympathectomy and sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with the extend of sympathetic resection.

Conditions

  • Hyperhidrosis

Interventions

PROCEDURE

Sympathectomy

Resection of ganglia at T3 level

PROCEDURE

Sympathicotomy

Cutting of symptahetic chain at T3 level without ganglia excision

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Mario Santini, MD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-09-30
Completion
2014-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733497 on ClinicalTrials.gov