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

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperhidrosis; Quality of Life

Intervention: Video-assisted sympathectomy (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
José Ribas M de Campos, Study Director, Affiliation: Professor of Thoracic Surgery - University of São Paulo - Medical College

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Assessment of quality of life.

Incidence of the compensatory hyperhidrosis

Intensity of the compensatory hyperhidrosis

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

Minimum age: 15 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Faculty of Medicine - University of São Paulo., São Paulo 05403-010, Brazil
Additional Information

Starting date: February 2007
Last updated: June 21, 2010

Page last updated: August 23, 2015

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