NCT06219655

Brief Summary

Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

January 18, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

January 4, 2024

Last Update Submit

January 12, 2024

Conditions

Hyperhidrosis Due to Autonomic Dysregulation (Disorder)

Outcome Measures

Primary Outcomes (2)

  • hyperhidrosis dryness of hands

    dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test

    from 2019-2023 over 4 years

  • dryness of both feet

    dryness of both hands and feet- difference in temperature hands and feet before and after-starch iodine test

    from 2019-2023 over 4 years

Study Arms (2)

Extended symathectomy

ACTIVE COMPARATOR
Procedure: thoracoscopic sympathectomy

limited sympathectomy

ACTIVE COMPARATOR
Procedure: thoracoscopic sympathectomy

Interventions

thoracoscopic sympathectomyPROCEDURE

sympathectomy

Extended symathectomylimited sympathectomy

Eligibility Criteria

Age6 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of hyperhydrosis
  • Able to take drugs
  • Palmer and planter hyperhydrosis
  • Age from 6-24 years
  • Interfere with daily activities

You may not qualify if:

  • Not fit for surgery
  • Thyroid disease
  • age less than 6 years
  • Chest or cardiac problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 7650005, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of vascular surgery

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 23, 2024

Study Start

January 18, 2019

Primary Completion

March 5, 2022

Study Completion

January 1, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations

EG(1)