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

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ClinicalTrials.gov Identifier: NCT03921320
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Miguel L. Tedde, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Primary Focal Palms Procedure: Bilateral sequential sympathectomy Procedure: Unilateral sympathectomy Procedure: Contralateral sympathectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921320


Contacts
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Contact: Niura N Hamiltopn, MD +55 (11) 2661-5708 niurinhaa@yahoo.com.br
Contact: Nelson Wolosker, MD,PhD nwolosker@yahoo.com.br

Locations
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Brazil
Hospital Universitário da Universidade Federal do Amazonas Recruiting
Manaus, AM, Brazil
Contact: Fernando L Westphal, MD, PhD       f.l.westphal@uol.com.br   
Hospital Santa Isabel Not yet recruiting
Salvador, BA, Brazil
Contact: Maira K Fernandes, MD       mairakalil@gmail.com   
Hospital Geral Dr. Cesar Cals Recruiting
Fortaleza, CE, Brazil
Contact: Alexandre M Lima, MD    +55 (11) 99603-8708    alexandremrl@gmail.com   
Instituto Hospital de Base Not yet recruiting
Brasília, DF, Brazil
Contact: Humberto A Oliveira, MD, PhD       humberto@respirardf.com.br   
Hospital Julia Kubitschek Recruiting
Belo Horizonte, MG, Brazil
Contact: Carla Maria S Alves, MD       carlamalves@terra.com.br   
Hospital Maternidade Terezinha de Jesus Recruiting
Juiz de Fora, MG, Brazil
Contact: Guilherme A Rodrigues, MD    +55 (11) 99992-5546    gui.armed@hotmail.com   
Hospital Universitário Oswaldo Cruz Recruiting
Recife, PE, Brazil
Contact: Alisson H Gonçalves, MD       aalissonh@icloud.com   
Hospital Universitário Pedro Ernesto Recruiting
Rio de Janeiro, RJ, Brazil
Contact: Carlos Eduardo T Lima, MD       carlostlima@globo.com   
Hospital Universitário Onofre Lopes Recruiting
Natal, RN, Brazil
Contact: Carlos Alberto A Araújo, MD, PhD       cabetoufrn@gmail.com   
Hospital Geral de Caxias do Sul Not yet recruiting
Caxias do Sul, RS, Brazil
Contact: Darcy R Pinto Filho, MD, PhD    +55 (54) 3228-4882    darcyrp@terra.com.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Chair: Miguel L Tedde, MD, PhD Thoracic Surgeon, InCor, FMUSP
More Information
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Responsible Party: Miguel L. Tedde, Thoracic surgeon, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03921320    
Other Study ID Numbers: Usaopaulo04032019
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel L. Tedde, University of Sao Paulo:
Hyperhidrosis
Sympathectomy
Sweating
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases