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

Primary Purpose

Hyperhidrosis, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Video-assisted sympathectomy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Thoracic sympathectomy, Objective measurement of sweat

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Medicine - University of São Paulo.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Objective measurement of sweat

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Assessment of quality of life.
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
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
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

Full Information

First Posted
June 7, 2010
Last Updated
June 21, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01140659
Brief Title
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Quality of Life
Keywords
Hyperhidrosis, Thoracic sympathectomy, Objective measurement of sweat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Objective measurement of sweat
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Video-assisted sympathectomy
Other Intervention Name(s)
Thoracic sympathectomy, Endoscopic thoracic sympathectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective measurement of sweat before and after surgery (video-assisted thoracic sympathectomy) T3 and T4.
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of quality of life.
Description
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.
Time Frame
12 months
Title
Incidence of the compensatory hyperhidrosis
Description
The incidence of compensatory sweating was reported spontaneously by patients during the postoperative evaluation (1 week, 1 month, 6 months and 12th month).
Time Frame
12 months
Title
Intensity of the compensatory hyperhidrosis
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Ribas M de Campos
Organizational Affiliation
Professor of Thoracic Surgery - University of São Paulo - Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine - University of São Paulo.
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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

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