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CompletedNCT06113978MISforPPHUpdated Nov 2, 2023

Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18

An interventional study of Thoracoscopic sympathectomy and Thoracoscopic sympathotomy in Hyperhidrosis, Children, Adolescents and Thoracoscopic Sympathetic Chain Interruption, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Egypt. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Non-randomized
Ages
6 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Palmar hyperhidrosis;
  • Thoracoscopic sympathectomy;
  • Compensatory sweating;
  • Pediatrics,
  • Adolescents
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 420 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

dr. Muhammad Abdelhafez Mahmoud, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • secondary hyperhidrosis,
  • nocturnal sweating,
  • recurrent cases, and
  • patients older than 18 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • ProcedureThoracoscopic 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.

  • ProcedureThoracoscopic 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.

  • ProcedureThoracoscopic 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.

06

What researchers measure

Primary outcomes

  1. success rate

    number of patients with post operative dry hands

    Time frame: 2 years

  2. compensatory sweating

    number of patients with post operative compensatory sweating

    Time frame: 2 years

  3. patient satisfaction rate

    number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)

    Time frame: 2 years

Secondary outcomes

  1. complications

    number of complications

    Time frame: 2 years

  2. recurrence rate

    number of recurrent cases

    Time frame: 2 years

07

Study locations

1 site
  • Pediatric Surgery Department, Al-Azhar University
    Cairo, 11651, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Clinical study report

Time frame: from today indefinitely

Access criteria: for other colleagues who may be interested with the study topic

Data sharing details ↗ · orcid.org

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06113978
Lead sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
Responsible party
dr. Muhammad Abdelhafez Mahmoud, MD (Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine, Al-Azhar University) — Sponsor-investigator
First posted
Nov 2, 2023
Start date
Sep 1, 2022
Primary completion
Mar 15, 2023
Completion
Aug 30, 2023
Last update
Nov 2, 2023

Study contacts

Mohamed Ahmed A Alzayyat, MD
study director · Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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