Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 200
- Locations
- 10
- Primary Endpoint
- Change of sweating intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
Bilateral sympathectomy
Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy
Intervention: Bilateral sequential sympathectomy (Procedure)
Unilateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side
Intervention: Unilateral sympathectomy (Procedure)
Contralateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side
Intervention: Contralateral sympathectomy (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Change of sweating intensity(Change from baseline sweating to 6 months after surgery)
- Change of sweating intensity(Change from baseline sweating to 6 months after sympathectomy)
Investigators
Miguel L. Tedde
Thoracic surgeon
University of Sao Paulo