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.
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
- Conditions the study is for
- Hyperhidrosis, Children, Adolescents, Thoracoscopic Sympathetic Chain Interruption
- 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.
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.
- Conditions
- Hyperhidrosis, Children, Adolescents, Thoracoscopic Sympathetic Chain Interruption, Sympathetic Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents | Active comparator | 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. Receives: Procedure: Thoracoscopic sympathectomy |
| Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescents | Active comparator | 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. Receives: Procedure: Thoracoscopic sympathotomy |
| Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescents | Active comparator | 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. Receives: Procedure: Thoracoscopic sympathetic chain clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
number of patients with post operative dry hands
Measured: 2 years
compensatory sweating
number of patients with post operative compensatory sweating
Measured: 2 years
patient satisfaction rate
number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)
Measured: 2 years
Secondary outcomes (2)
complications
number of complications
Measured: 2 years
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.
- First posted2 Nov 2023
- Study start1 Sep 2022
- Primary completion15 Mar 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
- Investigators
- Mohamed Ahmed A Alzayyat, MD, Study director, Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fifteen Years' Experience of Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Children and Adolescents; Evaluation of Different Techniques
- ClinicalTrials.gov ID
- NCT06113978
- Acronym / sponsor ID
- MISforPPH / AlAzharThoracoscSympathforPPH
- Conditions
- Hyperhidrosis, Children, Adolescents, Thoracoscopic Sympathetic Chain Interruption, Sympathetic Disorder
- Keywords
- Palmar hyperhidrosis;, Thoracoscopic sympathectomy;, Compensatory sweating;, Pediatrics,, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents | Active comparator | Procedure: Thoracoscopic sympathectomyMedical 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 | Active comparator | Procedure: Thoracoscopic sympathotomyMedical 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 | Active comparator | Procedure: Thoracoscopic sympathetic chain clippingMedical 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- secondary hyperhidrosis,
- nocturnal sweating,
- recurrent cases, and
- patients older than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracoscopic sympathectomyMedical 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 or surgery | Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents |
| Thoracoscopic sympathotomyMedical 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 or surgery | Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescents |
| Thoracoscopic sympathetic chain clippingMedical 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 or surgery | Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescents |
Primary outcome
success rate
Time frame: 2 years
number of patients with post operative dry hands
compensatory sweating
Time frame: 2 years
number of patients with post operative compensatory sweating
patient satisfaction rate
Time frame: 2 years
number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)
2 secondary outcomes
complications
Time frame: 2 years
recurrence rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ahmed A Alzayyat, MD study director
Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University
1 site in 1 country: see every site and its status.
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.