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

Study Overview
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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.

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

Conditions
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Hyperhidrosis Primary Focal Palms

Intervention / Treatment
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* Procedure: Bilateral sequential sympathectomy
* Procedure: Unilateral sympathectomy
* Procedure: Contralateral sympathectomy


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline sweating to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from baseline sweating to 6 months after sympathectomy | 
| 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 | Change from baseline sweating to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperhidrosis, Sympathectomy, Sweating