Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18 (MISforPPH)

Fifteen Years' Experience of Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Children and Adolescents; Evaluation of Different Techniques

In this study, the investigators aim to present fifteen years' experience of thoracoscopic sympathetic chain interruption for primary palmar hyperhidrosis in children and adolescents; evaluation of 3 different techniques (sympathectomy, sympathotomy, and clipping) regarding demographic data, surgical outcomes, complications, compensatory sweating, and patients' satisfaction.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis; Sympathetic Disorder; Children, Adolescents; Thoracoscopic Sympathetic Chain Interruption
• Intervention / Treatment: Procedure: Thoracoscopic sympathectomy; Procedure: Thoracoscopic sympathotomy; Procedure: Thoracoscopic sympathetic chain clipping

Detailed Description

Primary palmar hyperhidrosis (PPH) is a severely devastating autonomic disorder that can affect any patient regardless age, even pediatrics. Thoracoscopic sympathetic chain interruption offers a definitive effective therapy. In this study, the investigators aim to assess the outcomes of thoracoscopic management of palmar hyperhidrosis in a large cohort of children younger than 18 years old with severe PPH, using sympathetic chain interruption either by sympathectomy, sympathotomy or clipping, to provide a methodology focused on the long-term outcomes of those procedures.

Patients and Methods: This is a retrospective study that included all children who underwent thoracoscopic sympathectomy, sympathotomy, or clipping for severe PPH, from April 2008 to March 2023 were assessed retrospectively. Demographic data, postoperative outcome, complications, compensatory sweating and satisfaction were analyzed.

Surgical procedures:

General anesthesia was used, with an ordinary endotracheal tube, by an experienced anesthesiologist who used one lung ventilation anesthesia to control the patient's O2-enriched ventilation in a low-volume/high-frequency technique, with alternating brief periods of apnea. The patient was placed in the semi-Fowler position, which is the dorsal decubitus position with the arms abducted and fixed at 90 degrees. The trunk was elevated by 30-40 degrees; as elevation helped displace the lungs downwards. A slight bed elevation at the knee level was useful to safely place the patients and prevent them from slipping down during the procedure.

To access the thoracic cavity, the investigators used the two-port video thoracoscopy using two 5 mm ports via 2 mini-incisions. The camera (30º scope) port was placed laterally at the fourth or fifth intercostal space (depending on the age of the patient) just posterior to the anterior axillary fold created by the pectoralis major muscle. The second port (for electrocautery instrument (hook) was laterally inserted in the third/fourth intercostal space at the mid-axillary line as that approach provides excellent aesthetic results. A CO2 pneumothorax pressure of 5-8 mmHg was used according to patient's age and body built. The posterior parietal pleura was incised just lateral to neck of 3rd rib and further dissected down to identify the thoracic sympathetic chain.

A-Thoracoscopic sympathectomy: A segment of the thoracic sympathetic chain at the intended levels is resected using hook electrothermoablation.

B-Thoracoscopic sympathotomy technique (VATS): The sympathetic chain is just cut at the desired levels without excision.

C-Thoracoscopic clipping technique: Titanium clips are applied on the desired level without cutting. Then, after completion of the procedure, CO2 pneumothorax was deflated, permitting full lung inflation under vision, without need for chest tube placement, ports removal, and port-sites closure by absorbable sutures with full awake recovery from anesthesia. Post operative routine chest x-ray was done to detect any residual pneumothorax and to assess the location of clips in clipping group.

Statistical Analysis:

Data were collected, revised, coded, and entered to the Statistical Package for Social Science (SPSS), IBM, version 23. The qualitative data were presented as numbers and percentages, while the quantitative data were presented as means, standard deviations, and ranges when their distribution was found to be parametric. Independent t-test and Chi-square tests were used to compare both groups. The p-value was considered significant if < 0.05.

Discussion: will explore the different treatment modalities for PPH in children and adolescents, mentioning the medical/conservative methods, then focusing on the surgical option, that is thoracoscopic sympathetic chain interruption, either by sympathectomy, sympathotomy, and clipping for almost permanent remedy of PPH in pediatric age group younger than 18 years old. Points of discussion will include demographic data, follow-up period, surgical outcomes and complications, compensatory sweating, and patients' satisfaction.. The results obtained will be compared among the 3 groups and also compared to the previously published articles.

Finally, the investigators will conclude whether or not there is a better technique among the 3 modalities that gives the best durable outcome with the least complications.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Pediatric Surgery Department, Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• visible exaggerated bilateral symmetrical sweating with impaired daily activities (such as shaking hands, writing and drawing),
• without other apparent cause (e.g., hyperthyroidism, DM, or TB).

Exclusion Criteria:

• secondary hyperhidrosis,
• nocturnal sweating,
• recurrent cases, and
• patients older than 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathectomy.	Procedure: Thoracoscopic sympathectomy; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathectomy.
Active Comparator: Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescents; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, who underwent thoracoscopic bilateral simultaneous sympathotomy.	Procedure: Thoracoscopic sympathotomy; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, who underwent thoracoscopic bilateral simultaneous sympathotomy.
Active Comparator: Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescents; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, treated by thoracoscopic bilateral simultaneous sympathetic chain clipping.	Procedure: Thoracoscopic sympathetic chain clipping; Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, treated by thoracoscopic bilateral simultaneous sympathetic chain clipping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	number of patients with post operative dry hands	2 years
compensatory sweating	number of patients with post operative compensatory sweating	2 years
patient satisfaction rate	number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	number of complications	2 years
recurrence rate	number of recurrent cases	2 years

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Study Director: Mohamed Ahmed A Alzayyat, MD, Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Pediatrics,; Palmar hyperhidrosis;; Thoracoscopic sympathectomy;; Compensatory sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: AlAzharThoracoscSympathforPPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author but could not be sent owing to the medicolegal aspect of the hospital policy.
• IPD Sharing Time Frame: from today indefinitely
• IPD Sharing Access Criteria: for other colleagues who may be interested with the study topic
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Study Data/Documents

1. Study Protocol
   Information identifier: orcid.org/0000-0002-6328-6419
   Information comments: the corresponding author (sponsor/principal investigator) of this work can be contacted for help anytime by colleagues who concern

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No