NCT06113978

Brief Summary

In this study, the investigators aim to present fifteen years' experience of thoracoscopic sympathetic chain interruption for primary palmar hyperhidrosis in children and adolescents; evaluation of 3 different techniques (sympathectomy, sympathotomy, and clipping) regarding demographic data, surgical outcomes, complications, compensatory sweating, and patients' satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

October 27, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

Palmar hyperhidrosis;Thoracoscopic sympathectomy;Compensatory sweating;Pediatrics,Adolescents

Outcome Measures

Primary Outcomes (3)

  • success rate

    number of patients with post operative dry hands

    2 years

  • compensatory sweating

    number of patients with post operative compensatory sweating

    2 years

  • patient satisfaction rate

    number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)

    2 years

Secondary Outcomes (2)

  • complications

    2 years

  • recurrence rate

    2 years

Study Arms (3)

Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents

ACTIVE COMPARATOR

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathectomy.

Procedure: Thoracoscopic sympathectomy

Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescents

ACTIVE COMPARATOR

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, who underwent thoracoscopic bilateral simultaneous sympathotomy.

Procedure: Thoracoscopic sympathotomy

Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescents

ACTIVE COMPARATOR

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, treated by thoracoscopic bilateral simultaneous sympathetic chain clipping.

Procedure: Thoracoscopic sympathetic chain clipping

Interventions

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathectomy.

Thoracoscopic sympathectomy for palmar hyperhidrosis in children and adolescents

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, who underwent thoracoscopic bilateral simultaneous sympathotomy.

Thoracoscopic sympathotomy for palmar hyperhidrosis in children and adolescents

Medical file records of patients of both sexes, below 18 years of age, suffering from significant bilateral palmar hyperhidrosis, treated by thoracoscopic bilateral simultaneous sympathetic chain clipping.

Thoracoscopic sympathetic chain clipping for palmar hyperhidrosis in children and adolescents

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • visible exaggerated bilateral symmetrical sweating with impaired daily activities (such as shaking hands, writing and drawing),
  • without other apparent cause (e.g., hyperthyroidism, DM, or TB).

You may not qualify if:

  • secondary hyperhidrosis,
  • nocturnal sweating,
  • recurrent cases, and
  • patients older than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Surgery Department, Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

HyperhidrosisAutonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNervous System Diseases

Study Officials

  • Mohamed Ahmed A Alzayyat, MD

    Deputy Dean, professor, Pediatric Surgery Department, Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This retrospective study was conducted at the Department of pediatric surgery, Al-Azhar University Hospitals in the period from April 2008 to March 2023, involving patients of both sexes, below 18 years of age, suffering from severe bothersome bilateral palmar hyperhidrosis, managed by thoracoscopic bilateral simultaneous sympathetic chain interruption.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 2, 2023

Study Start

September 1, 2022

Primary Completion

March 15, 2023

Study Completion

August 30, 2023

Last Updated

November 2, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The datasets used and/or analyzed during the current study are available from the corresponding author but could not be sent owing to the medicolegal aspect of the hospital policy.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
from today indefinitely
Access Criteria
for other colleagues who may be interested with the study topic
More information

Available IPD Datasets

Study Protocol (orcid.org/0000-0002-6328-6419)Access

Locations