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Compensatory Sweating After Unilateral Sympathectomy on the Dominant Side or Bilateral Sequential Sympathectomy

Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03921320
Acronym
Universusbi
Enrollment
200
Registered
2019-04-19
Start date
2019-03-07
Completion date
2023-12-31
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperhidrosis Primary Focal Palms

Keywords

Hyperhidrosis, Sympathectomy, Sweating

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.

Interventions

PROCEDUREBilateral sequential sympathectomy

Bilateral videothoracoscopic sequential R4 sympathectomy

PROCEDUREUnilateral sympathectomy

Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)

PROCEDUREContralateral sympathectomy

Contralateral (left side) videothoracoscopic R4 sympathectomy

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Change of sweating intensityChange from baseline sweating to 6 months after surgeryTo utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis treated by bilateral sequential thoracic sympathectomy

Secondary

MeasureTime frameDescription
Change of sweating intensityChange from baseline sweating to 6 months after sympathectomyTo utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis submitted to unilateral sympathectomy on the dominant (right) side

Other

MeasureTime frameDescription
Change of Quality of lifeChange from baseline quality of life to 6 months after surgeryTo utilize the HidroQOL questionnaire to evaluate the change in quality of life

Countries

Brazil

Contacts

Primary ContactNiura N Hamiltopn, MD
niurinhaa@yahoo.com.br+55 (11) 2661-5708
Backup ContactNelson Wolosker, MD,PhD
nwolosker@yahoo.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026