| CTRI Number |
CTRI/2025/11/097245 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparitive Study Of Middle Ear Functions And Adenoid Hypertrophy in Pre and Post Adenoidectomy Patients in a Rural Tertiary Care Hospital in Central India |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshi Kesharwani |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Otorhinolaryngology, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9521428583 |
| Fax |
|
| Email |
minikesharwani31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Gaurkar |
| Designation |
Professor |
| Affiliation |
jnmc Dmiher sawangi wardha |
| Address |
Department of ENT,Block-C Ground floor,AVBRH,Sawangi,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422902992 |
| Fax |
|
| Email |
shaggy6486@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himanshi Kesharwani |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Otorhinolaryngology, Ground Floor, AVBRH Building, Sawangi Meghei wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9521428583 |
| Fax |
|
| Email |
minikesharwani31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Sawangi(Meghe),Wardha-442004, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe institute of higher education and research sawangimeghewardha |
| Address |
Sawangi(Meghe),Wardha-442004 Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshi Kesharwani |
Acharya Vinoba bhave Rural hospital |
Department of ENT Block C, Ground Floor AVBRH, Sawangi
Wardha
MAHARASHTRA |
9521428583
minikesharwani31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with adenoid hypertrophy
2. Patients with intact tympanic membrane |
|
| ExclusionCriteria |
| Details |
1.Patients below 5 years of age and above 20 years of age
2. Patients with tympanic membrane perforation
3. Previously operated patients of adenoidectomy
4. Patients with deviated nasal septum
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Assessment will be done at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |