Hyperhidrosis Primary Focal PalmsUniversusbiNCT03921320
Compensatory Sweating After Unilateral Sympathectomy on the Dominant Side or Bilateral Sequential Sympathectomy
A study testing Bilateral sequential sympathectomy, Unilateral sympathectomy and Contralateral sympathectomy in people with Hyperhidrosis Primary Focal Palms, run by University of Sao Paulo at 10 sites in Brazil.
Trial summary
The standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. High rates of compensatory sweating due to the surgical procedure are described in the literature. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis Primary Focal Palms
- What is being tested?
- Bilateral sequential sympathectomy, Unilateral sympathectomy and Contralateral sympathectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesBrazil
- Study dates
- 7 Mar 2019to Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index equal to or less than 28;
- Exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis;
Who cannot join
- Being sinister (or left-handed);
- Craneo-f acial or generalized hyperhidrosis;
- Coagulopathies;
- Previous thoracic surgery;
- Other comorbidities such as cardiological, metabolic, infectious or neoplastic diseases;
- Pregnancy;
Trial locations and contacts
10 sites in 1 country.
Nelson Wolosker, MD,PhD contact
10 sites in 1 country
Brazil10 sites, 10 recruiting
- Recruiting
Hospital Julia Kubitschek
Belo Horizonte, Minas Gerais
Carla Maria S Alves, MD, carlamalves@terra.com.br
- Not yet recruiting
Instituto Hospital de Base
Brasília, Federal District
Humberto A Oliveira, MD, PhD, humberto@respirardf.com.br
- Not yet recruiting
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul
Darcy R Pinto Filho, MD, PhD, +55 (54) 3228-4882, darcyrp@terra.com.br
- Recruiting
Hospital Geral Dr. Cesar Cals
Fortaleza, Ceará
Alexandre M Lima, MD, +55 (11) 99603-8708, alexandremrl@gmail.com
- Recruiting
Hospital Maternidade Terezinha de Jesus
Juiz de Fora, Minas Gerais
Guilherme A Rodrigues, MD, +55 (11) 99992-5546, gui.armed@hotmail.com
- Recruiting
Hospital Universitário da Universidade Federal do Amazonas
Manaus, Amazonas
Fernando L Westphal, MD, PhD, f.l.westphal@uol.com.br
- Recruiting
Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte
Carlos Alberto A Araújo, MD, PhD, cabetoufrn@gmail.com
- Recruiting
Hospital Universitário Oswaldo Cruz
Recife, Pernambuco
Alisson H Gonçalves, MD, aalissonh@icloud.com
- Recruiting
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro
Carlos Eduardo T Lima, MD, carlostlima@globo.com
- Not yet recruiting
Hospital Santa Isabel
Salvador, Estado de Bahia
Maira K Fernandes, MD, mairakalil@gmail.com
About this study
Official title: Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
The standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. High rates of compensatory sweating due to the surgical procedure are described in the literature. In the search for a reduction in this side effect, it is possible that unilateral sympathectomy in the dominant side obtains acceptable results and leads to less compensatory sweating with improvement of the quality of life. The aim of this study it to compare the intensity of compensatory sweating due to the standard treatment, that is, bilateral sequential videothoracoscopic sympathectomy in relation to unilateral thoracic sympathectomy on the dominant side.
- Conditions
- Hyperhidrosis Primary Focal Palms
- Being tested
- Bilateral sequential sympathectomy, Unilateral sympathectomy, Contralateral sympathectomy
- Keywords
- Hyperhidrosis, Sympathectomy, Sweating
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral sequential sympathectomyProcedure or surgery
Bilateral videothoracoscopic sequential R4 sympathectomy
Unilateral sympathectomyProcedure or surgery
Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)
Contralateral sympathectomyProcedure or surgery
Contralateral (left side) videothoracoscopic R4 sympathectomy
| Study group | Role | What they receive |
|---|---|---|
| Bilateral sympathectomy | Active comparator | Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy Receives: Procedure: Bilateral sequential sympathectomy |
| Unilateral sympathectomy | Experimental | Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side Receives: Procedure: Unilateral sympathectomy |
| Contralateral sympathectomy | Experimental | Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side Receives: Procedure: Contralateral sympathectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sweating intensity
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis treated by bilateral sequential thoracic sympathectomy
Measured: Change from baseline sweating to 6 months after surgery
Secondary outcomes (2)
Change of sweating intensity
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis submitted to unilateral sympathectomy on the dominant (right) side
Measured: Change from baseline sweating to 6 months after sympathectomy
Change of sweating intensity
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients submitted to contralateral (left side) sympathectomy after unilateral sympathectomy on the dominant side
Measured: Change from baseline sweating to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start7 Mar 2019
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperhidrosis Primary Focal PalmsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Model description
- Participants will be randomized to be submitted to sequential bilateral sympathectomy or unilateral sympathectomy on the dominant side. After 4 to 6 months participants of the unilateral group can make the contralateral sympathectomy
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Miguel L Tedde, MD, PhD, Study chair, Thoracic Surgeon, InCor, FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921320
- Sponsor's protocol ID
- Usaopaulo04032019
- Acronym
- Universusbi
- Status last verified
- Oct 2021
- First submitted
- 11 Mar 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT03921320
- Acronym / sponsor ID
- Universusbi / Usaopaulo04032019
- Conditions
- Hyperhidrosis Primary Focal Palms
- Keywords
- Hyperhidrosis, Sympathectomy, Sweating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Apr 2019 (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 standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. High rates of compensatory sweating due to the surgical procedure are described in the literature. In the search for a reduction in this side effect, it is possible that unilateral sympathectomy in the dominant side obtains acceptable results and leads to less compensatory sweating with improvement of the quality of life. The aim of this study it to compare the intensity of compensatory sweating due to the standard treatment, that is, bilateral sequential videothoracoscopic sympathectomy in relation to unilateral thoracic sympathectomy on the dominant side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized to be submitted to sequential bilateral sympathectomy or unilateral sympathectomy on the dominant side. After 4 to 6 months participants of the unilateral group can make the contralateral sympathectomy
| Arm | Type | Receives |
|---|---|---|
| Bilateral sympathectomy | Active comparator | Procedure: Bilateral sequential sympathectomyBilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy |
| Unilateral sympathectomy | Experimental | Procedure: Unilateral sympathectomyUnilateral videothoracoscopic R4 sympathectomy on the right (dominant) side |
| Contralateral sympathectomy | Experimental | Procedure: Contralateral sympathectomyUnilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index equal to or less than 28;
- Exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis;
Key exclusion criteria (6 listed)
- Being sinister (or left-handed);
- Craneo-f acial or generalized hyperhidrosis;
- Coagulopathies;
- Previous thoracic surgery;
- Other comorbidities such as cardiological, metabolic, infectious or neoplastic diseases;
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 |
|---|---|---|
| Bilateral sequential sympathectomyBilateral videothoracoscopic sequential R4 sympathectomy | Procedure or surgery | Bilateral sympathectomy |
| Unilateral sympathectomyUnilateral videothoracoscopic R4 sympathectomy in dominant side (right side) | Procedure or surgery | Unilateral sympathectomy |
| Contralateral sympathectomyContralateral (left side) videothoracoscopic R4 sympathectomy | Procedure or surgery | Contralateral sympathectomy |
Primary outcome
Change of sweating intensity
Time frame: Change from baseline sweating to 6 months after surgery
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis treated by bilateral sequential thoracic sympathectomy
2 secondary outcomes
Change of sweating intensity
Time frame: Change from baseline sweating to 6 months after sympathectomy
Change of sweating intensity
Time frame: Change from baseline sweating to 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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.
Nelson Wolosker, MD,PhD contact
Miguel L Tedde, MD, PhD study chair
Thoracic Surgeon, InCor, FMUSP
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral sequential sympathectomy, Unilateral sympathectomy and Contralateral sympathectomy in people with Hyperhidrosis Primary Focal Palms, run by University of Sao Paulo at 10 sites in Brazil.
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 6 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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 Niura N Hamiltopn, MD (+55 (11) 2661-5708, niurinhaa@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sweating intensity (time frame: Change from baseline sweating to 6 months after surgery). 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 12 Oct 2021.