Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18

NCT ID: NCT06113978

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-08-30

Brief Summary

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.

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.

Conditions

Hyperhidrosis; Children, Adolescents; Thoracoscopic Sympathetic Chain Interruption; Sympathetic Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Thoracoscopic sympathectomy

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Thoracoscopic sympathotomy

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Thoracoscopic sympathetic chain clipping

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

dr. Muhammad Abdelhafez Mahmoud, MD

OTHER

Sponsor Role: lead

Responsible Party

dr. Muhammad Abdelhafez Mahmoud, MD

Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohamed Ahmed A Alzayyat, MD

Role: STUDY_DIRECTOR

Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University

Locations

Pediatric Surgery Department, Al-Azhar University

Cairo, , Egypt

Countries

Egypt

Study Documents

Document Type: Study Protocol

the corresponding author (sponsor/principal investigator) of this work can be contacted for help anytime by colleagues who concern

View Document

Other Identifiers

AlAzharThoracoscSympathforPPH

Identifier Type: -

Identifier Source: org_study_id