Compensatory HyperhidrosisNCT07196319
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
An observational study of Compensatory Hyperhidrosis and Compensatory Sweating, run by Assiut University.
Trial summary
The goal of this study is to compare the proportion of compensatory hyperhidrosis patients after sympathectomy at T3 level and sympathectomy at T3-4 level. The main question it aims to answer is: can sympathectomyv at one level decrease the incidence of compensatory hyperhidrosis after primary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Compensatory Hyperhidrosis, Compensatory Sweating
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 25 Oct 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: population of study are patients with primary hyperhidrosis who are going through T3 or T3-4 sympathectomy.
Who may be able to join
- Patients diagnosed with primary hyperhidrosis
- Patients with palmar and\or axillary hyperhidrosis.
- Age ≥ 6 years
Who cannot join
- History of Prior thoracic surgery.
- History of prior disorder that cause hyperhidrosis ( obesity,autonomic neuropathy,menopause,gout,etc…)
- History of prior systemic diseases cause hyperhidrosis (hyperthyroidism,DM,pheochromocytoma,Parkinson's disease,etc…)
- Patients with psychological problems.
About this study
Official title: "From One Problem to Another, Comparing the Incidence of Compensatory Hyperhidrosis After T3 Vs. T3-4 Sympathectomy"
The goal of this study is to compare the proportion of compensatory hyperhidrosis patients after sympathectomy at T3 level and sympathectomy at T3-4 level. The main question it aims to answer is:
can sympathectomyv at one level decrease the incidence of compensatory hyperhidrosis after primary hyperhidrosis.
Read the detailed description
Primary hyperhidrosis is a chronic condition characterized by excessive sweating beyond physiological needs, commonly affecting the palms, axillae, face, or soles. This disorder is largely attributed to neurogenic hyperexcitability within the sympathetic nervous system's pathways innervating the eccrine sweat glands.When conservative treatments such as topical agents or oral medications fail, endoscopic thoracic sympathectomy (ETS) is considered an effective surgical option. However, a major postoperative complication is compensatory hyperhidrosis (CH)-the development of excessive sweating in previously unaffected areas such as the trunk, back, or thighs. CH can significantly impact patient satisfaction and quality of life, often becoming more distressing than the original condition.
The extent and level of sympathectomy have been proposed as key factors influencing the incidence and severity of CH. While higher levels or multilevel resections (e.g., T2-4) are associated with increased rates of CH, more limited approaches such as T3-only resection are thought to reduce this risk. However, definitive evidence comparing T3 versus T3-4 sympathectomy remains limited and inconsistent across studies.
This study aims to compare the incidence and severity of compensatory hyperhidrosis following T3 versus T3-4 sympathectomy for primary hyperhidrosis. Understanding these differences may help refine surgical approaches to minimize CH and improve patient outcomes.
- Conditions
- Compensatory Hyperhidrosis, Compensatory Sweating
- Keywords
- compensatory, hyperhidrosis, sympathectomy
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T3 sympathectomy | patients who underwent T3 sympathectomy for primary hyperhidrosis | |
| T3-4 sympathectomy | patients who underwent through T3-4 sympathectomy for primary hyperhidrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of compensatory hyperhidrosis following T3 versus T3-4 sympathectomy.
Measured: 1 year post-sympathectomy
Secondary outcomes (3)
severity of Compensatory hyperhidrosis by hyperhidrosis disease severity scale
- The sweating is never noticeable and doesn't interfere with daily activities.
- The sweating is tolerable but sometimes interferes with daily activities.
- The sweating is barely tolerable and frequently interferes with daily activities.
- The sweating is intolerable and always interferes with daily activities.
Measured: 1 year post sympathectomy
recurrence rates of primary hyperhidrosis
Measured: 1 year post sympathectomy
site of compensatory hyperhidrosis
Measured: 1year post sympathectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start15 Nov 2025 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion25 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Compensatory HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelmoneim Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196319
- Sponsor's protocol ID
- CH post T3 &T3-4 Sympathectomy
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
PubMed 19897823Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.
PubMed 152808434. Lin TS, et al. Clinical experience of thoracoscopic sympathetic block for primary hyperhidrosis: analysis of 3450 cases. J Thorac Cardiovasc Surg. 2001;121(3):566-74.
3. Hussein AF, et al. Unilevel (T3) versus Bilevel (T3 - T4) Sympathictomy in the Management of Palmar Hyperhidrosis: A Prospective Comparative Study. Clinics (Sao Paulo). 2024.
2. Liu X, Wang J, Liu Z, Sun X, Zheng J. Comparison of only T3 and T3-T4 sympathectomy for axillary hyperhidrosis: a retrospective study. J Thorac Dis. 2018;10(4):2095-101.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Licht PB, Pilegaard HK. Severity of compensatory sweating after thoracoscopic sympathectomy. Ann Thorac Surg. 2004 Aug;78(2):427-31. doi: 10.1016/j.athoracsur.2004.02.087.
PubMed 15276490
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "From One Problem to Another, Comparing the Incidence of Compensatory Hyperhidrosis After T3 Vs. T3-4 Sympathectomy"
- ClinicalTrials.gov ID
- NCT07196319
- Acronym / sponsor ID
- CH post T3 &T3-4 Sympathectomy
- Conditions
- Compensatory Hyperhidrosis, Compensatory Sweating
- Keywords
- compensatory, hyperhidrosis, sympathectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 25 Oct 2028 (estimated)
- First posted
- 29 Sep 2025 (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 study is to compare the proportion of compensatory hyperhidrosis patients after sympathectomy at T3 level and sympathectomy at T3-4 level. The main question it aims to answer is:
can sympathectomyv at one level decrease the incidence of compensatory hyperhidrosis after primary hyperhidrosis.
Detailed description
Primary hyperhidrosis is a chronic condition characterized by excessive sweating beyond physiological needs, commonly affecting the palms, axillae, face, or soles. This disorder is largely attributed to neurogenic hyperexcitability within the sympathetic nervous system's pathways innervating the eccrine sweat glands.When conservative treatments such as topical agents or oral medications fail, endoscopic thoracic sympathectomy (ETS) is considered an effective surgical option. However, a major postoperative complication is compensatory hyperhidrosis (CH)-the development of excessive sweating in previously unaffected areas such as the trunk, back, or thighs. CH can significantly impact patient satisfaction and quality of life, often becoming more distressing than the original condition.
The extent and level of sympathectomy have been proposed as key factors influencing the incidence and severity of CH. While higher levels or multilevel resections (e.g., T2-4) are associated with increased rates of CH, more limited approaches such as T3-only resection are thought to reduce this risk. However, definitive evidence comparing T3 versus T3-4 sympathectomy remains limited and inconsistent across studies.
This study aims to compare the incidence and severity of compensatory hyperhidrosis following T3 versus T3-4 sympathectomy for primary hyperhidrosis. Understanding these differences may help refine surgical approaches to minimize CH and improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T3 sympathectomy | – | –patients who underwent T3 sympathectomy for primary hyperhidrosis |
| T3-4 sympathectomy | – | –patients who underwent through T3-4 sympathectomy for primary hyperhidrosis |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- population of study are patients with primary hyperhidrosis who are going through T3 or T3-4 sympathectomy.
Key inclusion criteria (3 listed)
- Patients diagnosed with primary hyperhidrosis
- Patients with palmar and\or axillary hyperhidrosis.
- Age ≥ 6 years
Key exclusion criteria (4 listed)
- History of Prior thoracic surgery.
- History of prior disorder that cause hyperhidrosis ( obesity,autonomic neuropathy,menopause,gout,etc…)
- History of prior systemic diseases cause hyperhidrosis (hyperthyroidism,DM,pheochromocytoma,Parkinson's disease,etc…)
- Patients with psychological problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the incidence of compensatory hyperhidrosis following T3 versus T3-4 sympathectomy.
Time frame: 1 year post-sympathectomy
3 secondary outcomes
severity of Compensatory hyperhidrosis by hyperhidrosis disease severity scale
Time frame: 1 year post sympathectomy
recurrence rates of primary hyperhidrosis
Time frame: 1 year post sympathectomy
site of compensatory hyperhidrosis
Time frame: 1year post sympathectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 19897823Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
- Background: PubMed 15280843Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.
- Background4. Lin TS, et al. Clinical experience of thoracoscopic sympathetic block for primary hyperhidrosis: analysis of 3450 cases. J Thorac Cardiovasc Surg. 2001;121(3):566-74.
- Background3. Hussein AF, et al. Unilevel (T3) versus Bilevel (T3 - T4) Sympathictomy in the Management of Palmar Hyperhidrosis: A Prospective Comparative Study. Clinics (Sao Paulo). 2024.
- Background2. Liu X, Wang J, Liu Z, Sun X, Zheng J. Comparison of only T3 and T3-T4 sympathectomy for axillary hyperhidrosis: a retrospective study. J Thorac Dis. 2018;10(4):2095-101.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 15276490Licht PB, Pilegaard HK. Severity of compensatory sweating after thoracoscopic sympathectomy. Ann Thorac Surg. 2004 Aug;78(2):427-31. doi: 10.1016/j.athoracsur.2004.02.087.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Compensatory Hyperhidrosis and Compensatory Sweating, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
To compare the incidence of compensatory hyperhidrosis following T3 versus T3-4 sympathectomy. (time frame: 1 year post-sympathectomy). 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 NCT07196319, which also lists 7 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 3 Oct 2025.