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The Effect of Obesity on Ventilation Tube Insertion

The Effect of Obesity on Ventilation Tube Insertion

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01437436
Enrollment
120
Registered
2011-09-20
Start date
2010-10-31
Completion date
2012-06-30
Last updated
2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Otitis Media

Keywords

otitis media, obesity, ventilation tube

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).

Interventions

PROCEDUREventilation tube

ventilation tube insertion

Sponsors

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026