ClinicalTrials.Veeva

Menu

The Effect of Obesity on Ventilation Tube Insertion

S

Soon Chun Hyang University

Status

Unknown

Conditions

Otitis Media
Obesity

Treatments

Procedure: ventilation tube

Study type

Observational

Funder types

Other

Identifiers

NCT01437436
SCHBC-11501

Details and patient eligibility

About

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.

Full 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).

Enrollment

120 estimated patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

obesity
Description:
otitis media patient with obesity
Treatment:
Procedure: ventilation tube
non obesity
Description:
otitis media patient with non obesity
Treatment:
Procedure: ventilation tube

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems