Hyperhidrosis Primary Focal Palms Clinical Trial
— UniversusbiOfficial 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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 2023 |
| Est. primary completion date | June 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Body mass index equal to or less than 28; - Exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis; Exclusion Criteria: - 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; |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital Julia Kubitschek | Belo Horizonte | MG |
| Brazil | Instituto Hospital de Base | Brasília | DF |
| Brazil | Hospital Geral de Caxias do Sul | Caxias do Sul | RS |
| Brazil | Hospital Geral Dr. Cesar Cals | Fortaleza | CE |
| Brazil | Hospital Maternidade Terezinha de Jesus | Juiz de Fora | MG |
| Brazil | Hospital Universitário da Universidade Federal do Amazonas | Manaus | AM |
| Brazil | Hospital Universitário Onofre Lopes | Natal | RN |
| Brazil | Hospital Universitário Oswaldo Cruz | Recife | PE |
| Brazil | Hospital Universitário Pedro Ernesto | Rio de Janeiro | RJ |
| Brazil | Hospital Santa Isabel | Salvador | BA |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change of Quality of life | To utilize the HidroQOL questionnaire to evaluate the change in quality of life | Change from baseline quality of life to 6 months after surgery | |
| Primary | 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 | Change from baseline sweating to 6 months after surgery | |
| Secondary | 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 | Change from baseline sweating to 6 months after sympathectomy | |
| Secondary | 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 | Change from baseline sweating to 6 months after surgery |