Hyperhidrosis Primary Focal Palms
Conditions
Keywords
Hyperhidrosis, Primary focal hyperhidrosis
Brief summary
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.
Detailed description
The aims of this study are: 1. examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH) 2. examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation. 3. examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH 4. examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH. 5. determine postoperative complications of BTS among persons with PFH 6. examine the influence of BTS on quality of life among persons with PFH
Interventions
PROCEDUREThoracic Sympathectomy
Bilateral thoracoscopic sympathectomy will be performed with general anesthesia, using single lung ventilation and monopolar cautery for transection of the sympathetic chain. Persons with PFH who underwent the BTS were classified into three groups, depending the level of transaction of sympathetic chain: 1. transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4); 2. transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4) 3. transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..
Sponsors
Sohag University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation * b. Satisfactory CardioPulmonary Function
Exclusion criteria
* previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema * Secondary Hyperhidrosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing | Immediately After surgery | Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI) | From baseline to 3 months post-operation. | The DLQI will be administered preoperatively and at 3 months postoperatively to evaluate changes in quality of life. The DLQI is a 10-item questionnaire where higher scores indicate greater impairment. The primary endpoint will be the mean reduction in DLQI score from baseline to 3 months, with a reduction of ≥ 5 points considered clinically significant |
| Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS) | From 1 day post-operation to 1 month post-operation. | Postoperative pain will be assessed at regular intervals (1 day, 1 week, and 1 month post-surgery) using the Visual Analog Scale (VAS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain. The primary endpoint will be the mean VAS score at each time point, with pain reduction over time compared |
| Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS) | from time of operation for 3 months after operation | Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months |
Countries
Egypt
Contacts
Primary ContactMohamed Mokhtar, Resident Physician
Backup ContactEssam El Badry, Assistant Professor
Outcome results
None listed