Hyperhidrosis Primary Focal PalmsNCT06638827
Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis
A study testing Thoracic Sympathectomy in people with Hyperhidrosis Primary Focal Palms, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis Primary Focal Palms
- What is being tested?
- Thoracic Sympathectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Jun 2025
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation
- b. Satisfactory CardioPulmonary Function
Who cannot join
- previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema
- Secondary Hyperhidrosis
Trial locations and contacts
1 site in 1 country.
Essam El Badry, Assistant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, Sohag Governorate, 82738
Mohamed Mokhtar, Resident Physician, 00201095585485, Mohamed94Mokhtar@gmail.com
Essam El Badry, Assistant Professor, 00201093939202
About this study
Official title: Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis, Sohag University Hospital Experience
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.
Read the detailed description
The aims of this study are:
- examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)
- examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.
- examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH
- examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.
- determine postoperative complications of BTS among persons with PFH
- examine the influence of BTS on quality of life among persons with PFH
- Conditions
- Hyperhidrosis Primary Focal Palms
- Being tested
- Thoracic Sympathectomy
- Keywords
- Hyperhidrosis, Primary focal hyperhidrosis
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic SympathectomyProcedure or surgery
Also called Bilateral Thoracoscopic Sympathectomy
Bilateral thoracoscopic sympathectomy will be performed with general anesthesia, using single lung ventilation and monopolar cautery for transection of the sympathetic chain.
Persons with PFH who underwent the BTS were classified into three groups, depending the level of transaction of sympathetic chain:
- transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4);
- transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4)
- transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..
| Study group | Role | What they receive |
|---|---|---|
| Patients complaining of primary focal hyperhidrosis | Active comparator | This is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy. Receives: Procedure: Thoracic Sympathectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions.
Measured: Immediately After surgery
Secondary outcomes (4)
Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)
The DLQI will be administered preoperatively and at 3 months postoperatively to evaluate changes in quality of life. The DLQI is a 10-item questionnaire where higher scores indicate greater impairment. The primary endpoint will be the mean reduction in DLQI score from baseline to 3 months, with a reduction of ≥ 5 points considered clinically significant
Measured: From baseline to 3 months post-operation.
Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)
Postoperative pain will be assessed at regular intervals (1 day, 1 week, and 1 month post-surgery) using the Visual Analog Scale (VAS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain. The primary endpoint will be the mean VAS score at each time point, with pain reduction over time compared
Measured: From 1 day post-operation to 1 month post-operation.
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months
Measured: from time of operation for 3 months after operation
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months
Measured: From baseline to 3 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2024
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hyperhidrosis Primary Focal PalmsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Mokhtar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638827
- Sponsor's protocol ID
- Soh-Med-24-09-09MS
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
PubMed 15280848Doolabh N, Horswell S, Williams M, Huber L, Prince S, Meyer DM, Mack MJ. Thoracoscopic sympathectomy for hyperhidrosis: indications and results. Ann Thorac Surg. 2004 Feb;77(2):410-4; discussion 414. doi: 10.1016/j.athoracsur.2003.06.003.
PubMed 14759407Shabat S, Furman D, Kupietzky A, Srour B, Mordechai-Heyn T, Grinbaum R, Mazeh H, Mizrahi I. Long-term Outcomes of Endoscopic Thoracoscopic Sympathectomy for Primary Focal Palmar Hyperhidrosis: High Patient Satisfaction Rates Despite Significant Compensatory Hyperhidrosis. Surg Laparosc Endosc Percutan Tech. 2022 Dec 1;32(6):730-735. doi: 10.1097/SLE.0000000000001100.
PubMed 36130719Milanez de Campos JR, Kauffman P, Gomes O Jr, Wolosker N. Video-Assisted Thoracic Sympathectomy for Hyperhidrosis. Thorac Surg Clin. 2016 Aug;26(3):347-58. doi: 10.1016/j.thorsurg.2016.04.010.
PubMed 27427529Solish N, Wang R, Murray CA. Evaluating the patient presenting with hyperhidrosis. Thorac Surg Clin. 2008 May;18(2):133-140. doi: 10.1016/j.thorsurg.2008.01.002.
PubMed 18557587
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis, Sohag University Hospital Experience
- ClinicalTrials.gov ID
- NCT06638827
- Acronym / sponsor ID
- Soh-Med-24-09-09MS
- Conditions
- Hyperhidrosis Primary Focal Palms
- Keywords
- Hyperhidrosis, Primary focal hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Oct 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.
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.
Detailed description
The aims of this study are:
- examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)
- examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.
- examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH
- examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.
- determine postoperative complications of BTS among persons with PFH
- examine the influence of BTS on quality of life among persons with PFH
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients complaining of primary focal hyperhidrosis | Active comparator | Procedure: Thoracic SympathectomyThis is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation
- b. Satisfactory CardioPulmonary Function
Key exclusion criteria (2 listed)
- previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema
- Secondary Hyperhidrosis
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 |
|---|---|---|
| Thoracic SympathectomyAlso: Bilateral Thoracoscopic SympathectomyBilateral thoracoscopic sympathectomy will be performed with general anesthesia, using single lung ventilation and monopolar cautery for transection of the sympathetic chain. Persons with PFH who underwent the BTS were classified into three groups, depending the level of transaction of sympathetic chain: 1. transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4); 2. transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4) 3. transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3).. | Procedure or surgery | Patients complaining of primary focal hyperhidrosis |
Primary outcome
Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
Time frame: Immediately After surgery
Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions.
4 secondary outcomes
Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)
Time frame: From baseline to 3 months post-operation.
Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)
Time frame: From 1 day post-operation to 1 month post-operation.
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: from time of operation for 3 months after operation
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: From baseline to 3 months post-operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 15280848Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
- Results publication: PubMed 14759407Doolabh N, Horswell S, Williams M, Huber L, Prince S, Meyer DM, Mack MJ. Thoracoscopic sympathectomy for hyperhidrosis: indications and results. Ann Thorac Surg. 2004 Feb;77(2):410-4; discussion 414. doi: 10.1016/j.athoracsur.2003.06.003.
- Results publication: PubMed 36130719Shabat S, Furman D, Kupietzky A, Srour B, Mordechai-Heyn T, Grinbaum R, Mazeh H, Mizrahi I. Long-term Outcomes of Endoscopic Thoracoscopic Sympathectomy for Primary Focal Palmar Hyperhidrosis: High Patient Satisfaction Rates Despite Significant Compensatory Hyperhidrosis. Surg Laparosc Endosc Percutan Tech. 2022 Dec 1;32(6):730-735. doi: 10.1097/SLE.0000000000001100.
- Results publication: PubMed 27427529Milanez de Campos JR, Kauffman P, Gomes O Jr, Wolosker N. Video-Assisted Thoracic Sympathectomy for Hyperhidrosis. Thorac Surg Clin. 2016 Aug;26(3):347-58. doi: 10.1016/j.thorsurg.2016.04.010.
- Results publication: PubMed 18557587Solish N, Wang R, Murray CA. Evaluating the patient presenting with hyperhidrosis. Thorac Surg Clin. 2008 May;18(2):133-140. doi: 10.1016/j.thorsurg.2008.01.002.
- Individual participant dataSharing planned: Undecided
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.
Essam El Badry, Assistant Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Sympathectomy in people with Hyperhidrosis Primary Focal Palms, run by Sohag 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mokhtar, Resident Physician (00201095585485, Mohamed94Mokhtar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing (time frame: Immediately After surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638827, which also lists 5 linked publications.
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 15 Oct 2024.