The Effect of Obesity on Ventilation Tube Insertion

• Conditions: Otitis Media; Obesity
• Interventions: Procedure: ventilation tube

• Registration Number: NCT01437436
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2010-10
• Status Verified: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Last Update Submitted: 2011-09-21
• Last Update Posted: 2011-09-23
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obesity	ventilation tube	otitis media patient with obesity
non obesity	ventilation tube	otitis media patient with non obesity