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Clinical Trials/CTRI/2025/11/097245
CTRI/2025/11/097245
Not yet recruiting
Not Applicable

A comparative study of Middle Ear Functions and Adenoid Hypertrophy in Pre and Post Adenoidectomy Patients in a Rural Tertiary Care Hospital in Central India.

Datta Meghe institute of higher education and research sawangimeghewardha1 site in 1 country55 target enrollmentStarted: December 5, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Datta Meghe institute of higher education and research sawangimeghewardha
Enrollment
55
Locations
1
Primary Endpoint
In this study,Sample size of 55 patients will be examined and evaluated including patients attending Otorhinolaryngology OPD or emergency with complaints of nasal discharge, nasal obstruction and snoring, or referred from - General Medicine, Pediatrics, and other departments for the above complaints.

Overview

Brief Summary

Adenoid hypertrophy is a prevalent condition in Pediatric population, often leading to obstructive symptoms and complication such as otitis media with effusion (OME). OME is characterized by the accumulation of fluid in the middle ear without sings of acute infection, potentially resulting in hearing loss and speech delays. The degree of adenoid hypertrophy, graded from 1 to 4, is thought to influence the middle ear dysfunction. This study aiims to evaluate the correlation between the grade of adenoid hypertrophy and postoperative improvement in the middle ear function using various parameters like impedence and Diagnostic  nasal endoscopy (DNE) following adenoidectomy.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
5.00 Year(s) to 20.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed with adenoid hypertrophy
  • Patients with intact tympanic membrane.

Exclusion Criteria

  • 1.Patients below 5 years of age and above 20 years of age
  • Patients with tympanic membrane perforation
  • Previously operated patients of adenoidectomy
  • Patients with deviated nasal septum.

Outcomes

Primary Outcomes

In this study,Sample size of 55 patients will be examined and evaluated including patients attending Otorhinolaryngology OPD or emergency with complaints of nasal discharge, nasal obstruction and snoring, or referred from - General Medicine, Pediatrics, and other departments for the above complaints.

Time Frame: Assessment will be done at 4 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Datta Meghe institute of higher education and research sawangimeghewardha
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Himanshi Kesharwani

Datta Meghe Institute of Higher Education and Research

Study Sites (1)

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