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Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sympathectomy
Sympathicotomy
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring sympathectomy, sympathicotomy, heart rate variability,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sympathectomy Group

    Sympathicotomy Group

    Arm Description

    Excision of ganglia at T3 level

    Resection of sympathetic chain at T3 level

    Outcomes

    Primary Outcome Measures

    Heart Rate (HR) measured in beats/min

    Secondary Outcome Measures

    Post-operative complications
    Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)

    Full Information

    First Posted
    April 5, 2016
    Last Updated
    April 9, 2016
    Sponsor
    University of Campania "Luigi Vanvitelli"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02733497
    Brief Title
    Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis
    Official Title
    Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis: Results Of A Prospective, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperhidrosis
    Keywords
    sympathectomy, sympathicotomy, heart rate variability,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sympathectomy Group
    Arm Type
    Active Comparator
    Arm Description
    Excision of ganglia at T3 level
    Arm Title
    Sympathicotomy Group
    Arm Type
    Active Comparator
    Arm Description
    Resection of sympathetic chain at T3 level
    Intervention Type
    Procedure
    Intervention Name(s)
    Sympathectomy
    Intervention Description
    Resection of ganglia at T3 level
    Intervention Type
    Procedure
    Intervention Name(s)
    Sympathicotomy
    Intervention Description
    Cutting of symptahetic chain at T3 level without ganglia excision
    Primary Outcome Measure Information:
    Title
    Heart Rate (HR) measured in beats/min
    Time Frame
    7 days, 1, 3 and 6 months after operation
    Secondary Outcome Measure Information:
    Title
    Post-operative complications
    Time Frame
    Post-operative time and 7 days, 1, 3 and 6 months after operation
    Title
    Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
    Time Frame
    1, 3 and 6 months after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mario Santini, MD
    Organizational Affiliation
    University of Campania "Luigi Vanvitelli"
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17404794
    Citation
    Katara AN, Domino JP, Cheah WK, So JB, Ning C, Lomanto D. Comparing T2 and T2-T3 ablation in thoracoscopic sympathectomy for palmar hyperhidrosis: a randomized control trial. Surg Endosc. 2007 Oct;21(10):1768-71. doi: 10.1007/s00464-007-9241-9. Epub 2007 Apr 3.
    Results Reference
    background
    PubMed Identifier
    10219553
    Citation
    Tedoriya T, Sakagami S, Ueyama T, Thompson L, Hetzer R. Influences of bilateral endoscopic transthoracic sympathicotomy on cardiac autonomic nervous activity. Eur J Cardiothorac Surg. 1999 Feb;15(2):194-8. doi: 10.1016/s1010-7940(98)00309-1.
    Results Reference
    background
    PubMed Identifier
    19258086
    Citation
    Cruz J, Sousa J, Oliveira AG, Silva-Carvalho L. Effects of endoscopic thoracic sympathectomy for primary hyperhidrosis on cardiac autonomic nervous activity. J Thorac Cardiovasc Surg. 2009 Mar;137(3):664-9. doi: 10.1016/j.jtcvs.2008.07.021. Epub 2008 Sep 24.
    Results Reference
    background
    PubMed Identifier
    27889103
    Citation
    Fiorelli A, Messina G, Chiodini P, Costanzo S, Viggiano A, Monda M, Vicidomini G, Santini M. Cardiac Autonomic Changes After Thoracic Sympathectomy: A Prospective, Randomized Study. Ann Thorac Surg. 2017 Jan;103(1):216-224. doi: 10.1016/j.athoracsur.2016.10.055. Epub 2016 Nov 23.
    Results Reference
    derived

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    Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

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