NCT02728297

Brief Summary

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

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 1, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

6.1 years

First QC Date

March 27, 2016

Last Update Submit

April 4, 2016

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months

    decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale

    24 months

Study Arms (1)

Staged ETS

EXPERIMENTAL

Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side

Procedure: Staged ETS

Interventions

Staged ETSPROCEDURE

Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.

Staged ETS

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

You may not qualify if:

  • Patients under 16 years.
  • Patients with bradycardia (heart rate \<80 beats per minute).
  • Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
  • Patients with cardiac problems with ejection fraction less than 60%.
  • Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis.
  • Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sameh H Emile, M.D

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 5, 2016

Study Start

January 1, 2010

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

April 5, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)