Objective Evaluation of Patients With Palmar Hyperhidrosis Submitted to Two Levels of Sympathectomy: T3 and T4.

NCT01140659 | Completed

• 1 other identifier: 005/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the results obtained with video-assisted sympathectomy performed in two distinct levels ganglionic (third versus fourth thoracic ganglion) for the treatment of palmar hyperhidrosis, through a blind randomized clinical trial using an objective method to measure the sweat before and after the operation.

Conditions

Hyperhidrosis; Quality of Life

Keywords

Hyperhidrosis; Thoracic sympathectomy; Objective measurement of sweat

Outcome Measures

Primary Outcomes (1)

• Objective measurement of sweat before and after surgery (video-assisted thoracic sympathectomy) T3 and T4.

  We used an objective method for measuring sweat, checking the "TEWL (transepidermal water loss) measured by the"VapoMeter". This is a portable instrument that functions noninvasively. It has a closed measurement chamber that eliminates external interference from air currents and enables precise metering of transepidermal water loss (TEWL). The evaporation rate is calculated from the rise in relative air humidity inside the closed chamber of the device, and this value is quantified in g/m²/h (increase in the water mass per unit time per unit of evaporation area).

  12 months

Secondary Outcomes (3)

• Assessment of quality of life.

  12 months

• Incidence of the compensatory hyperhidrosis

  12 months

• Intensity of the compensatory hyperhidrosis

  12 months

Study Arms (1)

Objective measurement of sweat

OTHER

We selected 40 patients from February 2007 to May 2009. All participants were randomized into two groups of 20 patients (G3 and G4) and underwent the sympathectomy, being followed for 12 months. We used an objective method for measuring sweat, checking the "TEWL (transepidermal water loss) measured by the "VapoMeter", and evaluated the quality of life before and after the operation. Also studied were: incidence and intensity of the compensatory hyperhidrosis.

Procedure: Video-assisted sympathectomy

Interventions

Video-assisted sympathectomy PROCEDURE

All participants were randomized into two groups of 20 patients (G3 and G4) and underwent video-assisted sympathectomy, being followed for 12 months. During this period, the subjects completed a questionnaire about quality of life and carried out the measurements of sweat by VapoMeter.

Also known as: Thoracic sympathectomy, Endoscopic thoracic sympathectomy

Objective measurement of sweat

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being determined to accomplish the procedure, because such a statement depends on the level of discomfort suffered by the patient.
• Absence of previous thoracic surgery.
• Concordance with the completion of informed consent.
• Preoperative normal, including chest radiograph, electrocardiogram, blood count, sodium, potassium, urea, creatinine, glucose and thyroid hormones.

You may not qualify if:

• Patients with BMI\> 25.
• Pregnancy.
• Younger than 15 and more than 45 years.
• Heart disease that may contraindicate the procedure (congestive heart failure, coronary insufficiency, cardiac arrhythmias, symptomatic, acute myocardial infarction, etc.).
• Acute infections or chronic.
• Bleeding disorder.
• Neoplasms.
• Inflammatory diseases of pulmonary or pleural.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculty of Medicine - University of São Paulo.

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• José Ribas M de Campos

  Professor of Thoracic Surgery - University of São Paulo - Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: February 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 22, 2010

Record last verified: 2010-05

Locations

BR (1)