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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01140659
First received: June 7, 2010
Last updated: June 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Hyperhidrosis
Quality of Life
Procedure: Video-assisted sympathectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Objective Evaluation of Patients With Palmar Hyperhidrosis Submitted to Two Levels of Sympathectomy: T3 and T4.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Objective measurement of sweat before and after surgery (video-assisted thoracic sympathectomy) T3 and T4. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Assessment of quality of life. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    We evaluated the quality of life before and after operation by questionnaire supplied to patients.

    Quality of life before the treatment was classified into five different levels and calculated as the summed total score from the protocol (range from 20 to 100). When the total was greater than 84, the QOL was considered very poor; from 68 to 83 was considered poor; from 52 to 67 was good; from 36 to 51 was very good; and from 20 to 35 was excellent.

    After the treatment, the patients were asked to grade the improvement in each item of the same QOL questionnaire.


  • Incidence of the compensatory hyperhidrosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The incidence of compensatory sweating was reported spontaneously by patients during the postoperative evaluation (1 week, 1 month, 6 months and 12th month).

  • Intensity of the compensatory hyperhidrosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The intensity of compensatory hyperhidrosis (CH) reported spontaneously by patients was graded as severe or non-severe. CH was considered severe when the sweat was visible, thereby causing embarrassment and leading to the need to change clothes every day


Enrollment: 40
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Objective measurement of sweat
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
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.
Other Names:
  • Thoracic sympathectomy
  • Endoscopic thoracic sympathectomy

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

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140659

Locations
Brazil
Faculty of Medicine - University of São Paulo.
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: José Ribas M de Campos Professor of Thoracic Surgery - University of São Paulo - Medical College
  More Information

No publications provided

Responsible Party: Augusto Ishy / Thoracic surgeon in the thoracic surgery department of the "Hospital das Clínicas de São Paulo", Faculty of Medicine - University of São Paulo (FMUSP)
ClinicalTrials.gov Identifier: NCT01140659     History of Changes
Other Study ID Numbers: 005/05
Study First Received: June 7, 2010
Last Updated: June 21, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Hyperhidrosis
Thoracic sympathectomy
Objective measurement of sweat

Additional relevant MeSH terms:
Hyperhidrosis
Skin Diseases
Sweat Gland Diseases

ClinicalTrials.gov processed this record on November 25, 2014