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

University of Sao Paulo

Status: Unknown

Conditions: Hyperhidrosis Primary Focal Palms

Treatments: Procedure: Bilateral sequential sympathectomy; Procedure: Unilateral sympathectomy; Procedure: Contralateral sympathectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03921320

Usaopaulo04032019

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Bilateral sympathectomy

Active Comparator group

Description:

Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy

Treatment:

Procedure: Bilateral sequential sympathectomy

Unilateral sympathectomy

Experimental group

Description:

Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side

Treatment:

Procedure: Unilateral sympathectomy

Contralateral sympathectomy

Experimental group

Description:

Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

Treatment:

Procedure: Contralateral sympathectomy