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Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02733497
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Alfonso Fiorelli, University of Campania "Luigi Vanvitelli"

Brief 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.


Condition or disease Intervention/treatment Phase
Hyperhidrosis Procedure: Sympathectomy Procedure: Sympathicotomy Not Applicable

Detailed Description:

It was an unicenter prospective study performed at Thoracic Surgery Unit of Second University of Naples. Patients with severe EPH were randomly assigned to Sympathectomy or Sympathicotomy Group in 1:1 ratio .

Bilateral ETSs were performed in a one-stage procedure by the same surgeon. General anaesthesia using single-lung ventilation technique was performed and patient was placed in standard lateral thoracotomy position. Immediately after the induction of anaesthesia, a local infiltration with 2% lidocaine and epinephrine was injected at each port 5 minutes before the incision to reduce postoperative pain. The first port was placed in the 3th intercostal space below and anterior to inferior angle of scapula and through that a 10 mm 30 degree camera was inserted. A second 5 mm working port was placed at the same intercostal space in the anterior axillary line. After identification of sympathetic chain, in Sympathectomy Group the T3 ganglion was excised at the top of the third rib while in Sympathicotomy Group the sympathetic chain was resected between T2-T3 ganglia at the same level but the T3 ganglion was left intact. At the end of the procedure, a 16 F drainage was inserted through the port and the lung was re-inflated to allow the air drainage from pleural cavity and to prevent pneumothorax. The drain was subsequently removed.

All measurements on cardiac autonomic function were performed one week before ETS and different post-operative time-points (7 days, 1, 3 and 6 months after ETS). The results were prospectively registered and then retrospectively analyzed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis: Results Of A Prospective, Randomized Study
Study Start Date : January 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Sympathectomy Group
Excision of ganglia at T3 level
Procedure: Sympathectomy
Resection of ganglia at T3 level

Active Comparator: Sympathicotomy Group
Resection of sympathetic chain at T3 level
Procedure: Sympathicotomy
Cutting of symptahetic chain at T3 level without ganglia excision




Primary Outcome Measures :
  1. Heart Rate (HR) measured in beats/min [ Time Frame: 7 days, 1, 3 and 6 months after operation ]

Secondary Outcome Measures :
  1. Post-operative complications [ Time Frame: Post-operative time and 7 days, 1, 3 and 6 months after operation ]
  2. Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe) [ Time Frame: 1, 3 and 6 months after operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02733497


Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Study Chair: Mario Santini, MD University of Campania "Luigi Vanvitelli"

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alfonso Fiorelli, MD, PhD, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT02733497     History of Changes
Other Study ID Numbers: 1185/2011
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alfonso Fiorelli, University of Campania "Luigi Vanvitelli":
sympathectomy, sympathicotomy, heart rate variability,
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases