The Effect of Obesity on Ventilation Tube Insertion

Obesity Clinical Trial

Official title:

The Effect of Obesity on Ventilation Tube Insertion

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01437436
• Other study ID #: SCHBC-11501
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 19, 2011
• Last updated: September 21, 2011
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2011
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Otitis Media

Intervention

Procedure:
• ventilation tube
ventilation tube insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital