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NCT Number: NCT06638827

Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis

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.

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Key information

Conditions

Hyperhidrosis Primary Focal Palms Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, Sohag Governorate, 82738, Egypt

Location status: Recruiting

Location contact

Essam El Badry, Assistant Professor

CONTACT

00201093939202

Essam El Badry, Assistant Professor

SUB_INVESTIGATOR

Mohamed Mokhtar, Resident Physician

CONTACT

[email protected]

00201095585485

Mohsen Saber, Lecturer

SUB_INVESTIGATOR

About this study

The aims of this study are:

  • examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)
  • examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.
  • examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH
  • examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.
  • determine postoperative complications of BTS among persons with PFH
  • examine the influence of BTS on quality of life among persons with PFH

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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

Primary outcomes

  1. Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing

    Time frame: Immediately After surgery

    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.

Secondary outcomes

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

    Time frame: From baseline to 3 months post-operation.

    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

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

    Time frame: From 1 day post-operation to 1 month post-operation.

    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

  3. 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

    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

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

    Time frame: From baseline to 3 months post-operation.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Essam El Badry, Assistant Professor

CONTACT

00201093939202

Mohamed Mokhtar, Resident Physician

CONTACT

[email protected]

00201095585485

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Outcome Of Bilateral Thoracoscopic Sympathectomy for Patients With Primary Focal Hyperhidrosis, Sohag University Hospital Experience

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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