ClinicalTrials.gg
Status unknownNCT03921320UniversusbiUpdated Oct 12, 2021

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

An interventional study of Bilateral sequential sympathectomy and Unilateral sympathectomy in Hyperhidrosis Primary Focal Palms, sponsored by University of Sao Paulo. Status unknown at 10 sites in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperhidrosis Primary Focal Palms

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Keywords

  • Hyperhidrosis
  • Sympathectomy
  • Sweating
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Bilateral sympathectomy

    Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy

    Procedure: Bilateral sequential sympathectomy

  • Experimental
    Unilateral sympathectomy

    Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side

    Procedure: Unilateral sympathectomy

  • Experimental
    Contralateral sympathectomy

    Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side

    Procedure: Contralateral sympathectomy

Interventions

  • ProcedureBilateral sequential sympathectomy

    Bilateral videothoracoscopic sequential R4 sympathectomy

  • ProcedureUnilateral sympathectomy

    Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)

  • ProcedureContralateral sympathectomy

    Contralateral (left side) videothoracoscopic R4 sympathectomy

06

What researchers measure

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

    Time frame: Change from baseline sweating to 6 months after surgery

Secondary outcomes

  1. 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

    Time frame: Change from baseline sweating to 6 months after sympathectomy

  2. 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

    Time frame: Change from baseline sweating to 6 months after surgery

Other outcomes

  1. Change of Quality of life

    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

07

Study locations

7 of 10 sites recruiting
  • Hospital Universitário da Universidade Federal do Amazonas
    Manaus, AM, Brazil
    Recruiting
  • Hospital Santa Isabel
    Salvador, BA, Brazil
    Not yet recruiting
  • Hospital Geral Dr. Cesar Cals
    Fortaleza, CE, Brazil
    Recruiting
  • Instituto Hospital de Base
    Brasília, DF, Brazil
    Not yet recruiting
  • Hospital Julia Kubitschek
    Belo Horizonte, MG, Brazil
    Recruiting
  • Hospital Maternidade Terezinha de Jesus
    Juiz de Fora, MG, Brazil
    Recruiting
  • Hospital Universitário Oswaldo Cruz
    Recife, PE, Brazil
    Recruiting
  • Hospital Universitário Pedro Ernesto
    Rio de Janeiro, RJ, Brazil
    Recruiting
  • Hospital Universitário Onofre Lopes
    Natal, RN, Brazil
    Recruiting
  • Hospital Geral de Caxias do Sul
    Caxias do Sul, RS, Brazil
    Not yet recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Jun 2023, 51 months after the start.

Of 20 interventional studies with no phase under Hyperhidrosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2019
First posted
Apr 19, 2019
StartActual
Mar 7, 2019
Primary completionEst.
Jun 2023
CompletionEst.
Dec 2023
Last update
Oct 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03921320
Responsible party
Miguel L. Tedde (Thoracic surgeon, University of Sao Paulo) — Principal investigator
First posted
Apr 19, 2019
Start date
Mar 7, 2019
Primary completion
Jun 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Oct 12, 2021

Study contacts

Niura N Hamiltopn, MD
Contact
niurinhaa@yahoo.com.br
+55 (11) 2661-5708
Nelson Wolosker, MD,PhD
Contact
nwolosker@yahoo.com.br
Miguel L Tedde, MD, PhD
study chair · Thoracic Surgeon, InCor, FMUSP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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