Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis

NCT ID: NCT06638827

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperhidrosis Primary Focal Palms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Thoracic Sympathectomy

Intervention Type 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)..

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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. transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bilateral Thoracoscopic Sympathectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ashraf Mokhtar

Resident physician, Cardiothoracic Surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University

Sohag, Sohag Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Mokhtar, Resident Physician

Role: CONTACT

00201095585485

Essam El Badry, Assistant Professor

Role: CONTACT

00201093939202

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed Mokhtar, Resident Physician

Role: primary

00201095585485

Essam El Badry, Assistant Professor

Role: backup

00201093939202

Essam El Badry, Assistant Professor

Role: backup

Mohsen Saber, Lecturer

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14759407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15280848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36130719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27427529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18557587 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-24-09-09MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cryoablation vs Thoracoscopic Surgery for GGN
NCT06848881 NOT_YET_RECRUITING NA