Hyperhidrosis Due to Autonomic Dysregulation (Disorder)NCT06219655
Extended Versus Limited Thoracoscopic Sympathectomy: Its Impact on Palmar and Plantar Hyperhidrosis
A study testing thoracoscopic sympathectomy in people with Hyperhidrosis Due to Autonomic Dysregulation (Disorder), run by Mansoura University at 1 site in Egypt.
Trial summary
Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis. Read more about this study
- Who is it for?
- Ages 6 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis Due to Autonomic Dysregulation (Disorder)
- What is being tested?
- thoracoscopic sympathectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2019to 1 Jan 2024
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of hyperhydrosis
- Able to take drugs
- Palmer and planter hyperhydrosis
- Age from 6-24 years
- Interfere with daily activities
Who cannot join
- Not fit for surgery
- Thyroid disease
- age less than 6 years
- Chest or cardiac problems
Trial locations and contacts
1 site in 1 country.
About this study
Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.
Read the detailed description
ABSTRACT Objective: The aim was to carefully evaluate and compare the results of extended sympathectomy versus T3, T4, and T5 resection in cases of palmer, axillary, and planter hyperhidrosis as regards decreased sweating and recurrence rates.
Methods: This was a randomized controlled prospective trial conducted at the Department of Vascular Surgery Mansoura University Hospitals on a total of 120 patients with hyperhidrosis who were divided into two groups; group 1 who had undergone limited sympathectomy and group 2 who had undergone extended sympathectomy.
- Being tested
- thoracoscopic sympathectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic sympathectomyProcedure or surgery
sympathectomy
| Study group | Role | What they receive |
|---|---|---|
| Extended symathectomy | Active comparator | Not described Receives: Procedure: thoracoscopic sympathectomy |
| limited sympathectomy | Active comparator | Not described Receives: Procedure: thoracoscopic sympathectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperhidrosis dryness of hands
dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test
Measured: from 2019-2023 over 4 years
dryness of both feet
dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test
Measured: from 2019-2023 over 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start18 Jan 2019
- Primary completion5 Mar 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperhidrosis Due to Autonomic Dysregulation (Disorder)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed emad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219655
- Sponsor's protocol ID
- R.18.12.368.R1
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Versus Limited Thoracoscopic Sympathectomy: Its Impact on Palmar and Plantar Hyperhidrosis
- ClinicalTrials.gov ID
- NCT06219655
- Acronym / sponsor ID
- R.18.12.368.R1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Jan 2024 (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.
Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.
Detailed description
ABSTRACT Objective: The aim was to carefully evaluate and compare the results of extended sympathectomy versus T3, T4, and T5 resection in cases of palmer, axillary, and planter hyperhidrosis as regards decreased sweating and recurrence rates.
Methods: This was a randomized controlled prospective trial conducted at the Department of Vascular Surgery Mansoura University Hospitals on a total of 120 patients with hyperhidrosis who were divided into two groups; group 1 who had undergone limited sympathectomy and group 2 who had undergone extended sympathectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended symathectomy | Active comparator | Procedure: thoracoscopic sympathectomy |
| limited sympathectomy | Active comparator | Procedure: thoracoscopic sympathectomy |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of hyperhydrosis
- Able to take drugs
- Palmer and planter hyperhydrosis
- Age from 6-24 years
- Interfere with daily activities
Key exclusion criteria (4 listed)
- Not fit for surgery
- Thyroid disease
- age less than 6 years
- Chest or cardiac problems
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 sympathectomysympathectomy | Procedure or surgery | Extended symathectomy, limited sympathectomy |
Primary outcome
hyperhidrosis dryness of hands
Time frame: from 2019-2023 over 4 years
dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test
dryness of both feet
Time frame: from 2019-2023 over 4 years
dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test
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 23 Jan 2024.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Hyperhidrosis Due to Autonomic Dysregulation (Disorder), run by Mansoura University 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 5 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 23 Jan 2024. 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?
hyperhidrosis dryness of hands (time frame: from 2019-2023 over 4 years). The study lists 2 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 23 Jan 2024.