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

October 9, 2021 updated by: Miguel L. Tedde, University of Sao Paulo

Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • AM
      • Manaus, AM, Brazil
        • Recruiting
        • Hospital Universitário da Universidade Federal do Amazonas
        • Contact:
    • BA
      • Salvador, BA, Brazil
        • Not yet recruiting
        • Hospital Santa Isabel
        • Contact:
    • CE
      • Fortaleza, CE, Brazil
        • Recruiting
        • Hospital Geral Dr. Cesar Cals
        • Contact:
    • DF
      • Brasília, DF, Brazil
    • MG
      • Belo Horizonte, MG, Brazil
      • Juiz de Fora, MG, Brazil
        • Recruiting
        • Hospital Maternidade Terezinha de Jesus
        • Contact:
    • PE
      • Recife, PE, Brazil
        • Recruiting
        • Hospital Universitário Oswaldo Cruz
        • Contact:
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Recruiting
        • Hospital Universitário Pedro Ernesto
        • Contact:
    • RN
      • Natal, RN, Brazil
        • Recruiting
        • Hospital Universitário Onofre Lopes
        • Contact:
    • RS
      • Caxias do Sul, RS, Brazil
        • Not yet recruiting
        • Hospital Geral de Caxias do Sul
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bilateral sympathectomy
Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy
Procedure: Bilateral sequential sympathectomy
Bilateral videothoracoscopic sequential R4 sympathectomy
Experimental: Unilateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side
Procedure: Unilateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)
Experimental: Contralateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side
Procedure: Contralateral sympathectomy
Contralateral (left side) videothoracoscopic R4 sympathectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sweating intensity
Time Frame: 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
Change from baseline sweating to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sweating intensity
Time Frame: Change from baseline sweating to 6 months after sympathectomy
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 from baseline sweating to 6 months after sympathectomy
Change of sweating intensity
Time Frame: 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
Change from baseline sweating to 6 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Quality of life
Time Frame: Change from baseline quality of life to 6 months after surgery
To utilize the HidroQOL questionnaire to evaluate the change in quality of life
Change from baseline quality of life to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Miguel L Tedde, MD, PhD, Thoracic Surgeon, InCor, FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Usaopaulo04032019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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