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

Primary Purpose

Hyperhidrosis Primary Focal Palms

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilateral sequential sympathectomy
Unilateral sympathectomy
Contralateral sympathectomy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis Primary Focal Palms focused on measuring Hyperhidrosis, Sympathectomy, Sweating

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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;

Sites / Locations

  • Hospital Universitário da Universidade Federal do AmazonasRecruiting
  • Hospital Santa Isabel
  • Hospital Geral Dr. Cesar CalsRecruiting
  • Instituto Hospital de Base
  • Hospital Julia KubitschekRecruiting
  • Hospital Maternidade Terezinha de JesusRecruiting
  • Hospital Universitário Oswaldo CruzRecruiting
  • Hospital Universitário Pedro ErnestoRecruiting
  • Hospital Universitário Onofre LopesRecruiting
  • Hospital Geral de Caxias do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Bilateral sympathectomy

Unilateral sympathectomy

Contralateral sympathectomy

Arm Description

Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy

Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side

Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of sweating intensity
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis submitted to unilateral sympathectomy on the dominant (right) side
Change of sweating intensity
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

Full Information

First Posted
March 11, 2019
Last Updated
October 9, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03921320
Brief Title
Compensatory Sweating After Unilateral Sympathectomy on the Dominant Side or Bilateral Sequential Sympathectomy
Acronym
Universusbi
Official Title
Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis Primary Focal Palms
Keywords
Hyperhidrosis, Sympathectomy, Sweating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral sympathectomy
Arm Type
Active Comparator
Arm Description
Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy
Arm Title
Unilateral sympathectomy
Arm Type
Experimental
Arm Description
Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side
Arm Title
Contralateral sympathectomy
Arm Type
Experimental
Arm Description
Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side
Intervention Type
Procedure
Intervention Name(s)
Bilateral sequential sympathectomy
Intervention Description
Bilateral videothoracoscopic sequential R4 sympathectomy
Intervention Type
Procedure
Intervention Name(s)
Unilateral sympathectomy
Intervention Description
Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)
Intervention Type
Procedure
Intervention Name(s)
Contralateral sympathectomy
Intervention Description
Contralateral (left side) videothoracoscopic R4 sympathectomy
Primary Outcome Measure Information:
Title
Change of sweating intensity
Description
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis treated by bilateral sequential thoracic sympathectomy
Time Frame
Change from baseline sweating to 6 months after surgery
Secondary Outcome Measure Information:
Title
Change of sweating intensity
Description
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis submitted to unilateral sympathectomy on the dominant (right) side
Time Frame
Change from baseline sweating to 6 months after sympathectomy
Title
Change of sweating intensity
Description
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
Time Frame
Change from baseline sweating to 6 months after surgery
Other Pre-specified Outcome Measures:
Title
Change of Quality of life
Description
To utilize the HidroQOL questionnaire to evaluate the change in quality of life
Time Frame
Change from baseline quality of life to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niura N Hamiltopn, MD
Phone
+55 (11) 2661-5708
Email
niurinhaa@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Nelson Wolosker, MD,PhD
Email
nwolosker@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel L Tedde, MD, PhD
Organizational Affiliation
Thoracic Surgeon, InCor, FMUSP
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitário da Universidade Federal do Amazonas
City
Manaus
State/Province
AM
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando L Westphal, MD, PhD
Email
f.l.westphal@uol.com.br
Facility Name
Hospital Santa Isabel
City
Salvador
State/Province
BA
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maira K Fernandes, MD
Email
mairakalil@gmail.com
Facility Name
Hospital Geral Dr. Cesar Cals
City
Fortaleza
State/Province
CE
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre M Lima, MD
Phone
+55 (11) 99603-8708
Email
alexandremrl@gmail.com
Facility Name
Instituto Hospital de Base
City
Brasília
State/Province
DF
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humberto A Oliveira, MD, PhD
Email
humberto@respirardf.com.br
Facility Name
Hospital Julia Kubitschek
City
Belo Horizonte
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Maria S Alves, MD
Email
carlamalves@terra.com.br
Facility Name
Hospital Maternidade Terezinha de Jesus
City
Juiz de Fora
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme A Rodrigues, MD
Phone
+55 (11) 99992-5546
Email
gui.armed@hotmail.com
Facility Name
Hospital Universitário Oswaldo Cruz
City
Recife
State/Province
PE
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisson H Gonçalves, MD
Email
aalissonh@icloud.com
Facility Name
Hospital Universitário Pedro Ernesto
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo T Lima, MD
Email
carlostlima@globo.com
Facility Name
Hospital Universitário Onofre Lopes
City
Natal
State/Province
RN
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Alberto A Araújo, MD, PhD
Email
cabetoufrn@gmail.com
Facility Name
Hospital Geral de Caxias do Sul
City
Caxias do Sul
State/Province
RS
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darcy R Pinto Filho, MD, PhD
Phone
+55 (54) 3228-4882
Email
darcyrp@terra.com.br

12. IPD Sharing Statement

Learn more about this trial

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

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