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HyperhidrosisMISforPPHNCT06113978

Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18

A study testing Thoracoscopic sympathectomy, Thoracoscopic sympathotomy and Thoracoscopic sympathetic chain clipping in people with Hyperhidrosis and Children, Adolescents, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 14 years
What is being tested?
Thoracoscopic sympathectomy, Thoracoscopic sympathotomy and Thoracoscopic sympathetic chain clipping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 30 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Pediatric Surgery Department, Al-Azhar University

    Cairo, 11651

Other trials in Egypt

About this study

Official title: 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.

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.

Being tested
Thoracoscopic sympathectomy, Thoracoscopic sympathotomy, Thoracoscopic sympathetic chain clipping
Keywords
Palmar hyperhidrosis;, Thoracoscopic sympathectomy;, Compensatory sweating;, Pediatrics,, Adolescents
Medical subject headings
Hyperhidrosis, Autonomic Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracoscopic sympathectomyProcedure or surgery

    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 sympathotomyProcedure or surgery

    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 clippingProcedure or surgery

    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.

Study groups in NCT06113978
Study groupRoleWhat they receive
Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescentsActive comparatorMedical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathectomy.
Receives: Procedure: Thoracoscopic sympathectomy
Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescentsActive comparatorMedical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, who underwent thoracoscopic bilateral simultaneous sympathotomy.
Receives: Procedure: Thoracoscopic sympathotomy
Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescentsActive comparatorMedical 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.
Receives: Procedure: Thoracoscopic sympathetic chain clipping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. success rate

    number of patients with post operative dry hands

    Measured: 2 years

  2. compensatory sweating

    number of patients with post operative compensatory sweating

    Measured: 2 years

  3. patient satisfaction rate

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

    Measured: 2 years

Secondary outcomes (2)
  1. complications

    number of complications

    Measured: 2 years

  2. recurrence rate

    number of recurrent cases

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start1 Sep 2022
  3. Primary completion15 Mar 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113978
Sponsor's protocol ID
AlAzharThoracoscSympathforPPH
Acronym
MISforPPH
Status last verified
Nov 2023
First submitted
27 Oct 2023
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Thoracoscopic sympathectomy, Thoracoscopic sympathotomy and Thoracoscopic sympathetic chain clipping in people with Hyperhidrosis and Children, Adolescents, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

success rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.

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