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Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

NCT ID: NCT02512770

Last Updated: 2015-07-31

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

Detailed Description

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Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

Conditions

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Obstruction of Esophagus Respiratory Complication Hemodynamic Instability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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dilatation

esaphageal dilatation group

Group Type EXPERIMENTAL

endoscopic dilatation

Intervention Type PROCEDURE

control

control group ( only endoscopy for control)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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endoscopic dilatation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* endoscopy for esaphageal dilatation and control
* ASA I-III
* 0-16 year old

Exclusion Criteria

* ASA IV
* endoscopy for removing foreing body
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ayse Cigdem Tutuncu

OTHER

Sponsor Role collaborator

Senol Emre

UNKNOWN

Sponsor Role collaborator

Fatis Altindas

UNKNOWN

Sponsor Role collaborator

Kaya, Guner, M.D.

INDIV

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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pinar kendigelen

M.D.(Anesthesiology Specialist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guner Kaya, Prof.

Role: STUDY_DIRECTOR

Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University

Other Identifiers

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270718

Identifier Type: -

Identifier Source: org_study_id