Clinical trial NCT03921320: Compensatory Sweating After Unilateral Sympathectomy on the Dominant Side or Bilateral Sequential Sympathectomy
Official title: Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperhidrosis Primary Focal Palms
Keywords: Hyperhidrosis
Sympathectomy
Sweating
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change of sweating intensity
timeFrame: Change from baseline sweating to 6 months after surgery
Secondary outcomes:
measure: Change of sweating intensity
timeFrame: Change from baseline sweating to 6 months after sympathectomy
measure: Change of sweating intensity
timeFrame: Change from baseline sweating to 6 months after surgery
Other outcomes:
measure: Change of Quality of life
timeFrame: Change from baseline quality of life to 6 months after surgery
Locations:
city: Manaus
country: Brazil
facility: Hospital Universitário da Universidade Federal do Amazonas
state: AM
city: Salvador
country: Brazil
facility: Hospital Santa Isabel
state: BA
city: Fortaleza
country: Brazil
facility: Hospital Geral Dr. Cesar Cals
state: CE
city: Brasília
country: Brazil
facility: Instituto Hospital de Base
state: DF
city: Belo Horizonte
country: Brazil
facility: Hospital Julia Kubitschek
state: MG
city: Juiz de Fora
country: Brazil
facility: Hospital Maternidade Terezinha de Jesus
state: MG
city: Recife
country: Brazil
facility: Hospital Universitário Oswaldo Cruz
state: PE
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
state: RJ
city: Natal
country: Brazil
facility: Hospital Universitário Onofre Lopes
state: RN
city: Caxias do Sul
country: Brazil
facility: Hospital Geral de Caxias do Sul
state: RS
Study officials:
affiliation: Thoracic Surgeon, InCor, FMUSP
name: Miguel L Tedde, MD, PhD
role: STUDY_CHAIR
References: