Clinical trial NCT06113978: Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18
Official title: Fifteen Years' Experience of Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Children and Adolescents; Evaluation of Different Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Children, Adolescents
Thoracoscopic Sympathetic Chain Interruption
Sympathetic Disorder
Keywords: Palmar hyperhidrosis;
Thoracoscopic sympathectomy;
Compensatory sweating;
Pediatrics,
Adolescents
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 420
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This retrospective study was conducted at the Department of pediatric surgery, Al-Azhar University Hospitals in the period from April 2008 to March 2023, involving patients of both sexes, below 18 years of age, suffering from severe bothersome bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathetic chain interruption.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: success rate
timeFrame: 2 years
measure: compensatory sweating
timeFrame: 2 years
measure: patient satisfaction rate
timeFrame: 2 years
Secondary outcomes:
measure: complications
timeFrame: 2 years
measure: recurrence rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Surgery Department, Al-Azhar University
Study officials:
affiliation: Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University
name: Mohamed Ahmed A Alzayyat, MD
role: STUDY_DIRECTOR
References: