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Completed

NCT Number: NCT01140659

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

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.

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Key information

Conditions

Hyperhidrosis Quality of Life Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine - University of São Paulo.

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Thoracic sympathectomy, Endoscopic thoracic sympathectomy

Primary outcomes

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

    Time frame: 12 months

    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 outcomes

  1. Assessment of quality of life.

    Time frame: 12 months

    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.

  2. Incidence of the compensatory hyperhidrosis

    Time frame: 12 months

    The incidence of compensatory sweating was reported spontaneously by patients during the postoperative evaluation (1 week, 1 month, 6 months and 12th month).

  3. Intensity of the compensatory hyperhidrosis

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jun 9, 2010
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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