Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

NCT ID: NCT02728297

Last Updated: 2016-04-05

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Conditions

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Hyperhidrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Staged ETS

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

Group Type EXPERIMENTAL

Staged ETS

Intervention Type PROCEDURE

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.

Interventions

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Staged ETS

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura32

Identifier Type: -

Identifier Source: org_study_id

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