Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

NCT02733497 | Completed DMC

• 1 other identifier: 1185/2011
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperhidrosis

Keywords

sympathectomy, sympathicotomy, heart rate variability,

Outcome Measures

Primary Outcomes (1)

• Heart Rate (HR) measured in beats/min

  7 days, 1, 3 and 6 months after operation

Secondary Outcomes (2)

• Post-operative complications

  Post-operative time and 7 days, 1, 3 and 6 months after operation

• Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)

  1, 3 and 6 months after operation

Study Arms (2)

Sympathectomy Group

ACTIVE COMPARATOR

Excision of ganglia at T3 level

Procedure: Sympathectomy

Sympathicotomy Group

ACTIVE COMPARATOR

Resection of sympathetic chain at T3 level

Procedure: Sympathicotomy

Interventions

Sympathectomy PROCEDURE

Resection of ganglia at T3 level

Sympathectomy Group

Sympathicotomy PROCEDURE

Cutting of symptahetic chain at T3 level without ganglia excision

Sympathicotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years
• Severe hyperhidrosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (4)

• 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.

  PMID: 17404794 BACKGROUND

• 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.

  PMID: 10219553 BACKGROUND

• 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.

  PMID: 19258086 BACKGROUND

• 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.

  PMID: 27889103 DERIVED

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Sympathectomy

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Autonomic Denervation; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Mario Santini, MD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 12, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share