CompletedNot Applicable

Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

60 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age more than 18 years * Severe hyperhidrosis Exclusion Criteria: * Contraindications for general anaesthetic procedure and/or for selective endotracheal intubation * Previous pleural or lung diseases that make difficult the access to pleural cavityù * Cardiac diseases and/or taking medications with cardiac effects * Secondary hyperhidrosis including hyperthyroidism, acute and chronic infections, malignancy, and immunologic disorder * Mild or moderate palmar hyperhidrosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Rate (HR) measured in beats/min

Timeframe: 7 days, 1, 3 and 6 months after operation

Trial details

NCT IDNCT02733497

SponsorUniversity of Campania Luigi Vanvitelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Hyperhidrosis trials