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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.
The aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients complaining of primary focal hyperhidrosis | Active Comparator | This is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Sympathectomy | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing | 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. | Immediately After surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Mokhtar, Resident Physician | Contact | 00201095585485 | Mohamed94Mokhtar@gmail.com | |
| Essam El Badry, Assistant Professor | Contact | 00201093939202 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Recruiting | Sohag | Sohag Governorate | 82738 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15280848 | Result | 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. | |
| 14759407 |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
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| From baseline to 3 months post-operation. |
| Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS) | 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 | 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) | 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 | from time of operation for 3 months after operation |
| Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS) | 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 | From baseline to 3 months post-operation. |
| 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. |
| 36130719 | Result | 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. |
| 27427529 | Result | 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. |
| 18557587 | Result | 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. |