| CTRI Number |
CTRI/2025/06/089833 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the postoperative hearing outcomes in patients with chronic otitis media after Ossiculoplasty |
|
Scientific Title of Study
|
To Compare The Postoperative Hearing Outcomes In Patients With Chronic Otitis Media After Ossiculoplasty Using Autologous Cartilage And Synthetic Prosthesis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9028738326 |
| Fax |
|
| Email |
drmpatel85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Versha Singh |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
2013010
India |
| Phone |
9027248035 |
| Fax |
|
| Email |
singhversha246@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Versha Singh |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
2013010
India |
| Phone |
9027248035 |
| Fax |
|
| Email |
singhversha246@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences(GIMS) Kasna Greater Noida
Uttar Pradesh India
Pin-201310
|
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences Greater Noida |
| Address |
Kasna Greater Noida
Uttar Pradesh
India
Pin-201310 |
| Type of Sponsor |
Government 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 Monika Patel |
Government Institute of Medical Sciences (GIMS) |
Department of Otorhinolaryngology and Head Neck Surgery
Gautam Buddha Nagar
UTTAR PRADESH |
9028738326
drmpatel85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autograft |
From baseline to end of study at 7th day, 15th day, 90th day and 180 day |
| Comparator Agent |
synthetic prosthesis |
From Baseline to end of the study at the time point 7th day, 15th day, 90th day, 180 day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Age 18-50 years.
-Inactive mucosal chronic otitis media
-Air bone gap of more than 25 dB and ossicular chain necrosis.
-Good cochlear reserve.
-Normal eustachian tube function.
-Patients willing to participate and who provide informed written consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
-Active mucosal chronic otitis media
-Active squamosal chronic otitis media
-Inactive squamosal chronic otitis media
-Patients with sensorineural hearing loss
-Patients with complications of CSOM
-Revision surgery
-Otosclerosis /Fixed stapes footplate
-Patients with only functioning ear
-Patients with Chronic Tonsillitis and Adenoid Hypertrophy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pure Tone Average |
Pre- and postoperative PTA (usually average of 0.5, 1, 2, 3 kHz)
in Decibels. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Speech Discrimination Score (SDS): Improvement or stability postoperatively
-Graft Integration / Extrusion Rate: Incidence of graft failure or extrusion
-Revision Surgery Requirement: Need for revision ossiculoplasty or tympanoplasty
-Middle Ear Status (on follow-up): Middle ear mucosa, eustachian tube function. |
from baseline to end of treatment |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aim: To compare the hearing outcomes in patients of chronic otitis media using autologous cartilage and synthetic prosthesis after ossiculoplasty. Objectives 1. To evaluate the hearing outcomes in terms of air bone gap closure in each group after ossiculoplasty. 2. To compare the accuracy of prognostic indices with hearing outcomes after ossiculoplasty. Operational Definitions Chronic Suppurative Otitis Media (CSOM): A chronic inflammation of the middle ear and mastoid cavity is characterized by persistent or recurrent ear discharge through a perforated tympanic membrane, lasting more than 6–12 weeks. Ossiculoplasty: A surgical procedure to reconstruct the ossicular chain in the middle ear to restore sound transmission often performed in CSOM patients with ossicular erosion or discontinuity. Autologous Cartilage: Cartilage tissue harvested from the patient’s own body, used as a biological material to reconstruct the ossicular chain. Synthetic Prosthesis: Man-made materials such as teflon are used as prosthesis for ossicular chain reconstruction. Active (mucosal) Chronic otitis Media : Permanent defect of the pars tensa where there is an inflamed middle ear mucosa which produces mucopus. Active (squamosal) Chronic otitis Media: Retraction of the pars flaccida or tensa that has retained squamous epithelial debris and is 8 associated with cholesteatoma formation. Inactive (squamosal) Chronic otitis media : Retraction of the pars flaccida or pars tensa (usually poster superior) which is self cleansing. Good Cochlear Reserve: A good cochlear reserve means that the inner ear (cochlea) remains capable of adequately perceiving sound once sound conduction is restored. Clinically, it is indicated by near-normal bone conduction thresholds on pure tone audiometry. Post-operative Hearing Outcome: The change in auditory function is measured by pure tone audiometry (PTA), specifically assessed by air-bone gap (ABG) closure and improvement from preoperative values. Air-Bone Gap (ABG): It is the difference (in decibels) between air conduction and bone conduction thresholds on PTA. It is used to quantify conductive hearing loss. |