Clinical trial NCT02733497: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Keywords: sympathectomy, sympathicotomy, heart rate variability,
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Heart Rate (HR) measured in beats/min
timeFrame: 7 days, 1, 3 and 6 months after operation
Secondary outcomes:
measure: Post-operative complications
timeFrame: Post-operative time and 7 days, 1, 3 and 6 months after operation
measure: Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
timeFrame: 1, 3 and 6 months after operation
Other outcomes:
Locations:
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Mario Santini, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.