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

NCT03921320 | Unknown

• 1 other identifier: Usaopaulo04032019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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.

Conditions

Hyperhidrosis Primary Focal Palms

Keywords

Hyperhidrosis; Sympathectomy; Sweating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of sweating intensity

  Change from baseline sweating to 6 months after sympathectomy

• Change of sweating intensity

  Change from baseline sweating to 6 months after surgery

Other Outcomes (1)

• Change of Quality of life

  Change from baseline quality of life to 6 months after surgery

Study Arms (3)

Bilateral sympathectomy

ACTIVE COMPARATOR

Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy

Procedure: Bilateral sequential sympathectomy

Unilateral sympathectomy

EXPERIMENTAL

Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side

Procedure: Unilateral sympathectomy

Contralateral sympathectomy

EXPERIMENTAL

Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

Procedure: Contralateral sympathectomy

Interventions

Bilateral sequential sympathectomy PROCEDURE

Bilateral videothoracoscopic sequential R4 sympathectomy

Bilateral sympathectomy

Unilateral sympathectomy PROCEDURE

Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)

Unilateral sympathectomy

Contralateral sympathectomy PROCEDURE

Contralateral (left side) videothoracoscopic R4 sympathectomy

Contralateral sympathectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index equal to or less than 28;
• Exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (10)

Hospital Universitário da Universidade Federal do Amazonas

Manaus, Amazonas, Brazil

RECRUITING

Hospital Geral Dr. Cesar Cals

Fortaleza, Ceará, Brazil

RECRUITING

Hospital Santa Isabel

Salvador, Estado de Bahia, Brazil

NOT YET RECRUITING

Instituto Hospital de Base

Brasília, Federal District, Brazil

NOT YET RECRUITING

Hospital Julia Kubitschek

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

Hospital Maternidade Terezinha de Jesus

Juiz de Fora, Minas Gerais, Brazil

RECRUITING

Hospital Universitário Oswaldo Cruz

Recife, Pernambuco, Brazil

RECRUITING

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

RECRUITING

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Miguel L Tedde, MD, PhD

  Thoracic Surgeon, InCor, FMUSP

  STUDY CHAIR

Central Study Contacts

Niura N Hamiltopn, MD

CONTACT

+55 (11) 2661-5708; niurinhaa@yahoo.com.br

Nelson Wolosker, MD,PhD

CONTACT

nwolosker@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic surgeon

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 19, 2019
• Study Start: March 7, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

BR (10)