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

Not Applicable

• Conditions: Hyperhidrosis Primary Focal Palms
• Interventions: Procedure: Unilateral sympathectomy; Procedure: Bilateral sequential sympathectomy; Procedure: Contralateral sympathectomy

• Registration Number: NCT03921320
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-12
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral sympathectomy	Unilateral sympathectomy	Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side
Bilateral sympathectomy	Bilateral sequential sympathectomy	Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy
Contralateral sympathectomy	Contralateral sympathectomy	Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

Primary Outcome Measures

Name	Time	Method
Change of sweating intensity	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

Secondary Outcome Measures

Name	Time	Method
Change of sweating intensity	Change from baseline sweating to 6 months after surgery	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

Trial Locations

Locations (10)

Hospital Universitário Pedro Ernesto; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital Universitário da Universidade Federal do Amazonas; 🇧🇷 Manaus, AM, Brazil

Hospital Santa Isabel; 🇧🇷 Salvador, BA, Brazil

Hospital Geral Dr. Cesar Cals; 🇧🇷 Fortaleza, CE, Brazil

Instituto Hospital de Base; 🇧🇷 Brasília, DF, Brazil

Hospital Universitário Oswaldo Cruz; 🇧🇷 Recife, PE, Brazil

Hospital Geral de Caxias do Sul; 🇧🇷 Caxias do Sul, RS, Brazil

Hospital Julia Kubitschek; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Universitário Onofre Lopes; 🇧🇷 Natal, RN, Brazil

Hospital Maternidade Terezinha de Jesus; 🇧🇷 Juiz de Fora, MG, Brazil