Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis

NCT06638827 | Recruiting

• 1 other identifier: Soh-Med-24-09-09MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis Primary Focal Palms

Keywords

Hyperhidrosis; Primary focal hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)

  From baseline to 3 months post-operation.

• Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)

  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)

  from time of operation for 3 months after operation

• Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)

  From baseline to 3 months post-operation.

Study Arms (1)

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.

Procedure: Thoracic Sympathectomy

Interventions

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: 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)..

Also known as: Bilateral Thoracoscopic Sympathectomy

Patients complaining of primary focal hyperhidrosis

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema
• Secondary Hyperhidrosis

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82738, Egypt

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohamed Mokhtar, Resident Physician

CONTACT

00201095585485; Mohamed94Mokhtar@gmail.com

Essam El Badry, Assistant Professor

CONTACT

00201093939202

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician, Cardiothoracic Surgery department

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)