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Status unknownNCT01437436Updated Sep 23, 2011

The Effect of Obesity on Ventilation Tube Insertion

An observational study in Otitis Media and Obesity, sponsored by Soonchunhyang University Hospital. Status unknown. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2011-09-23.

Sponsored by Soonchunhyang University Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
2 Years to 15 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Otitis Media
  • Obesity

Keywords

  • otitis media
  • obesity
  • ventilation tube
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's planned enrollment of 120 is below the median of 165 across 63 observational studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Soonchunhyang University Hospital is the lead sponsor of 61 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Residents of bucheon city in South Korea

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)

Groups and cohorts

  • obesity

    otitis media patient with obesity

    Procedure: ventilation tube

  • non obesity

    otitis media patient with non obesity

    Procedure: ventilation tube

Interventions

  • Procedureventilation tube

    ventilation tube insertion

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01437436
Lead sponsor
Soonchunhyang University Hospital
Responsible party
Park Moo Kyun (Assistant professor, Soonchunhyang University Hospital) — Principal investigator
First posted
Sep 20, 2011
Start date
Oct 2010
Primary completion
Jun 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Sep 23, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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