Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis

Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis, Sohag University Hospital Experience

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperhidrosis Primary Focal Palms
• Intervention / Treatment: Procedure: Thoracic Sympathectomy

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Mokhtar, Resident Physician; Phone Number: 00201095585485; Email: Mohamed94Mokhtar@gmail.com
• Study Contact Backup: Name: Essam El Badry, Assistant Professor; Phone Number: 00201093939202

Study Locations

• Egypt
  • Sohag, Egypt, 82738
    • Recruiting
    • Sohag University
    • Contact: Mohamed Mokhtar, Resident Physician; Phone Number: 00201095585485; Email: Mohamed94Mokhtar@gmail.com
    • Contact: Essam El Badry, Assistant Professor; Phone Number: 00201093939202
    • Contact: Essam El Badry, Assistant Professor
    • Contact: Mohsen Saber, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Patients complaining of primary focal hyperhidrosis; This is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy.

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: transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4);; transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4); transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..; Other Names: Bilateral Thoracoscopic Sympathectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Primary focal hyperhidrosis; Hyperhidrosis
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: Soh-Med-24-09-09MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No