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

NCT ID: NCT03921320

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-07

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Hyperhidrosis Primary Focal Palms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral sympathectomy

Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy

Group Type ACTIVE_COMPARATOR

Bilateral sequential sympathectomy

Intervention Type PROCEDURE

Bilateral videothoracoscopic sequential R4 sympathectomy

Unilateral sympathectomy

Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side

Group Type EXPERIMENTAL

Unilateral sympathectomy

Intervention Type PROCEDURE

Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)

Contralateral sympathectomy

Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

Group Type EXPERIMENTAL

Contralateral sympathectomy

Intervention Type PROCEDURE

Contralateral (left side) videothoracoscopic R4 sympathectomy

Interventions

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Bilateral sequential sympathectomy

Bilateral videothoracoscopic sequential R4 sympathectomy

Intervention Type PROCEDURE

Unilateral sympathectomy

Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)

Intervention Type PROCEDURE

Contralateral sympathectomy

Contralateral (left side) videothoracoscopic R4 sympathectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Miguel L. Tedde

Thoracic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel L Tedde, MD, PhD

Role: STUDY_CHAIR

Thoracic Surgeon, InCor, FMUSP

Locations

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Hospital Universitário da Universidade Federal do Amazonas

Manaus, Amazonas, Brazil

Site Status RECRUITING

Hospital Geral Dr. Cesar Cals

Fortaleza, Ceará, Brazil

Site Status RECRUITING

Hospital Santa Isabel

Salvador, Estado de Bahia, Brazil

Site Status NOT_YET_RECRUITING

Instituto Hospital de Base

Brasília, Federal District, Brazil

Site Status NOT_YET_RECRUITING

Hospital Julia Kubitschek

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Hospital Maternidade Terezinha de Jesus

Juiz de Fora, Minas Gerais, Brazil

Site Status RECRUITING

Hospital Universitário Oswaldo Cruz

Recife, Pernambuco, Brazil

Site Status RECRUITING

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Countries

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Brazil

Central Contacts

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Niura N Hamiltopn, MD

Role: CONTACT

+55 (11) 2661-5708

Nelson Wolosker, MD,PhD

Role: CONTACT

Facility Contacts

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Fernando L Westphal, MD, PhD

Role: primary

Alexandre M Lima, MD

Role: primary

+55 (11) 99603-8708

Maira K Fernandes, MD

Role: primary

Humberto A Oliveira, MD, PhD

Role: primary

Carla Maria S Alves, MD

Role: primary

Guilherme A Rodrigues, MD

Role: primary

+55 (11) 99992-5546

Alisson H Gonçalves, MD

Role: primary

Carlos Eduardo T Lima, MD

Role: primary

Carlos Alberto A Araújo, MD, PhD

Role: primary

Darcy R Pinto Filho, MD, PhD

Role: primary

+55 (54) 3228-4882

Other Identifiers

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Usaopaulo04032019

Identifier Type: -

Identifier Source: org_study_id

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