Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic Sympathectomy.
- Who it may be relevant to
- Registry conditions: Hyperhidrosis Primary Focal Palms. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis, Sohag University Hospital Experience
Overview
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
- Procedure Thoracic 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
Primary outcome measures
- Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing [Time frame: Immediately After surgery]
Secondary outcome measures (4)
- Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI) [Time frame: From baseline to 3 months post-operation.]
- Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS) [Time frame: From 1 day post-operation to 1 month post-operation.]
- Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS) [Time frame: from time of operation for 3 months after operation]
- Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS) [Time frame: From baseline to 3 months post-operation.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Egypt · 1 center
- Sohag University — Sohag
Publications
- 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. PMID 15280848
- 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. PMID 14759407
- 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. PMID 36130719
- 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. PMID 27427529
- 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. PMID 18557587
Identifiers
NCT: NCT06638827 · Soh-Med-24-09-09MS