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The Effect of Obesity on Ventilation Tube Insertion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Park Moo Kyun, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01437436
First received: September 19, 2011
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Otitis Media
Obesity
 Procedure: ventilation tube

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Obesity on Ventilation Tube Insertion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
obesity
otitis media patient with obesity
 Procedure: ventilation tube
ventilation tube insertion
non obesity
otitis media patient with non obesity
 Procedure: ventilation tube
ventilation tube insertion

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).

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of bucheon city in South Korea

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Park Moo Kyun, Assistant professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01437436     History of Changes
Other Study ID Numbers: SCHBC-11501
Study First Received: September 19, 2011
Last Updated: September 21, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Soonchunhyang University Hospital:
otitis media
obesity
ventilation tube

Additional relevant MeSH terms:
Obesity
Otitis
Otitis Media
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013