NCT01437436

The Effect of Obesity on Ventilation Tube Insertion

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Otitis Media
• Obesity

Interventions

Type	Name	Description
PROCEDURE	ventilation tube	ventilation tube insertion

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-09-20
• Last updated: 2011-09-23