Clinical trial NCT01140659: Objective Evaluation of Patients With Palmar Hyperhidrosis Submitted to Two Levels of Sympathectomy: T3 and T4.
Official title: Objective Evaluation of Patients With Palmar Hyperhidrosis Submitted to Two Levels of Sympathectomy: T3 and T4.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Quality of Life
Keywords: Hyperhidrosis
Thoracic sympathectomy
Objective measurement of sweat
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Currently, the treatment of choice for treating palmar hyperhidrosis (PH) is video-assisted thoracic sympathectomy (VATS) . This minimally invasive technique has been well standardized and provides adequate results with low morbidity.

The main side effect of VATS is compensatory hyperhidrosis (CH). This is present in most cases and is considered the greatest cause of dissatisfaction. To reduce the risk of CH, various studies have been conducted to compare different levels of ganglion resection. These studies have been based on subjective quantification of sweating (assessment of sweating reported by patients) and on the application of quality-of-life questionnaires.

Recently, tests for the objective evaluation of sweating have been developed to quantify sweating among patients with various diseases, including PH. So far, there have not been any studies comparing the long-term results of thoracic sympathectomy on the third ganglion (G3) versus the fourth ganglion (G4)with objective evaluation to quantify sweating.

The present study was prospective, randomized and blinded, with the objective of comparing the results from VATS at two different resection levels: G3 versus G4. All the patients were followed over a one-year period, and their palmar sweating was quantified using a portable device (VapoMeter) to measure transepidermal water loss (TEWL). In addition, CH was evaluated by applying a specific quality-of-life questionnaire.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective measurement of sweat before and after surgery (video-assisted thoracic sympathectomy) T3 and T4.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of quality of life.
timeFrame: 12 months
measure: Incidence of the compensatory hyperhidrosis
timeFrame: 12 months
measure: Intensity of the compensatory hyperhidrosis
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculty of Medicine - University of São Paulo.
Study officials:
affiliation: Professor of Thoracic Surgery - University of São Paulo - Medical College
name: José Ribas M de Campos
role: STUDY_DIRECTOR
References: