Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis

Not Applicable

Completed

• Conditions: Hyperhidrosis
• Interventions: Procedure: Sympathectomy; Procedure: Sympathicotomy

• Registration Number: NCT02733497
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-09
• Study First Posted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sympathectomy Group	Sympathectomy	Excision of ganglia at T3 level
Sympathicotomy Group	Sympathicotomy	Resection of sympathetic chain at T3 level

Primary Outcome Measures

Name	Time	Method
Heart Rate (HR) measured in beats/min	7 days, 1, 3 and 6 months after operation

Secondary Outcome Measures

Name	Time	Method
Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)	1, 3 and 6 months after operation
Post-operative complications	Post-operative time and 7 days, 1, 3 and 6 months after operation