Clinical trial NCT06638827: Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis
Official title: Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis, Sohag University Hospital Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperhidrosis Primary Focal Palms
Keywords: Hyperhidrosis
Primary focal hyperhidrosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
timeFrame: Immediately After surgery
Secondary outcomes:
measure: Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)
timeFrame: From baseline to 3 months post-operation.
measure: Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)
timeFrame: From 1 day post-operation to 1 month post-operation.
measure: Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: from time of operation for 3 months after operation
measure: Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: From baseline to 3 months post-operation.
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
citation: Doolabh N, Horswell S, Williams M, Huber L, Prince S, Meyer DM, Mack MJ. Thoracoscopic sympathectomy for hyperhidrosis: indications and results. Ann Thorac Surg. 2004 Feb;77(2):410-4; discussion 414. doi: 10.1016/j.athoracsur.2003.06.003.
citation: Shabat S, Furman D, Kupietzky A, Srour B, Mordechai-Heyn T, Grinbaum R, Mazeh H, Mizrahi I. Long-term Outcomes of Endoscopic Thoracoscopic Sympathectomy for Primary Focal Palmar Hyperhidrosis: High Patient Satisfaction Rates Despite Significant Compensatory Hyperhidrosis. Surg Laparosc Endosc Percutan Tech. 2022 Dec 1;32(6):730-735. doi: 10.1097/SLE.0000000000001100.
citation: Milanez de Campos JR, Kauffman P, Gomes O Jr, Wolosker N. Video-Assisted Thoracic Sympathectomy for Hyperhidrosis. Thorac Surg Clin. 2016 Aug;26(3):347-58. doi: 10.1016/j.thorsurg.2016.04.010.
citation: Solish N, Wang R, Murray CA. Evaluating the patient presenting with hyperhidrosis. Thorac Surg Clin. 2008 May;18(2):133-140. doi: 10.1016/j.thorsurg.2008.01.002.