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The Effect of Obesity on Ventilation Tube Insertion

NCT ID: NCT01437436

Last Updated: 2011-09-23

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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Obesity is associated with increased risk of surgical complications. Ventilation tube insertion is one of the most frequent surgical procedures performed on children. However, the impact of obesity on surgical results or surgical related complication following ventilation tube insertion remains poorly understood. The aim of this study was to investigate the effect of obesity on the surgical results of ventilation tube insertion for otitis media with effusion (OME) in pediatric patients.

Detailed Description

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OME was diagnosed by the presence of fluid in the middle ear on otoscopy or tympanometry according to clinical practice guidelines . The diagnostic findings of pneumatic otoscopy and otomicroscopy include the tympanic membrane dullness, impaired mobility, and an air-fluid level or bubble. In addition, the type B or C tympanogram was considered positive for OME.

Indication for ventilation tub insertion includes history of OME lasting 3 months or longer, structural damage to tympanic membrane or middle ear and risk for speech, language learning difficulties. Adenoidectomy is also performed when adenoid hypertrophy is founded during preoperative assessment.

Body weight and height were measured before ventilation tube insertion at hospital. Body mass index (BMI) was calculated using the formula weight/ height2 (Kg/m2).

Conditions

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Otitis Media Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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obesity

otitis media patient with obesity

ventilation tube

Intervention Type PROCEDURE

ventilation tube insertion

non obesity

otitis media patient with non obesity

ventilation tube

Intervention Type PROCEDURE

ventilation tube insertion

Interventions

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ventilation tube

ventilation tube insertion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged 2-15 years with a diagnosis of OME who underwent ventilation tube insertion

Exclusion Criteria

* Children with a previous history of ventilation tube insertion
* Use of ventilation tubes other than Paparella type I
* Head and neck anomalies
* Chronic or systemic disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Park Moo Kyun

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SCHBC-11501

Identifier Type: -

Identifier Source: org_study_id