| CTRI Number |
CTRI/2024/10/074840 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Outcomes of Myringoplasty with and without Cortical Mastoidectomy for Chronic Otitis Media Without Cholesteatoma |
|
Scientific Title of Study
|
A Comparative study of myringoplasty with and without cortical mastoidectomy in treatment of chronic otitis media without choleasteatoma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAISHALI GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. Rajendra prasad medical College and hospital |
| Address |
ENT department, Dr. Rajendra prasad medical college , KANGRA AT TANDA Dr. Rajendra prasad medical College and hospital, kangra at tanda, hp Kangra HIMACHAL PRADESH 176001 India |
| Phone |
8091093206 |
| Fax |
|
| Email |
vishuchd34@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MUNISH SAROCH |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
Dr. Rajendra prasad medical College and hospital |
| Address |
ENT department, Dr. Rajendra prasad medical college, Kangra at Tanda Dr. Rajendra prasad medical College and hospital, kangra at tanda, hp Kangra HIMACHAL PRADESH 176001 India |
| Phone |
9418037099 |
| Fax |
|
| Email |
drsaroch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
VAISHALI GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. Rajendra prasad medical College and hospital |
| Address |
ENT DEPARTMENT, Dr.Rajendra prasad medical college , KANGRA AT TANDA Dr. Rajendra prasad medical College and hospital, kangra at tanda, hp Kangra HIMACHAL PRADESH 176001 India |
| Phone |
8091093206 |
| Fax |
|
| Email |
vishuchd34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. rajendra prasad medical college, kangra at tanda, 176001 |
|
|
Primary Sponsor
|
| Name |
DR Rajendra Prasad Medical College |
| Address |
DR RPGMC, KANGRA AT TANDA |
| 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 vaishali gupta |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
department of ent, room nos 210 , Dr Rajendra Prasad Government Medical College Kangra at Tanda Kangra HIMACHAL PRADESH |
8091093206
vishuchd34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India – 176 001 Institutional Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic ear discharge (Chronic Suppurative Otitis Media, safe type) attending the ENT OPD at Dr. RPGMC Tanda, Kangra.
Age group 18 to 60 years.
Both genders.
Unilateral or bilateral disease.
|
|
| ExclusionCriteria |
| Details |
Patients above the age of 60 years or below 18 years.
Chronic Suppurative Otitis Media, unsafe type.
Debilitated and immunocompromised patients.
Pregnant and lactating women.
Patients with external or middle ear abnormalities (congenital or acquired). |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
graft success rate
hearing improvement
reoccurrence of disease |
baseline, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
18/10/2024 |
| 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 Applicable |
| 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
|
The World Health Organization defines chronic suppurative otitis media (CSOM) as a persistent middle ear infection with a perforated tympanic membrane, leading to chronic discharge and hearing loss. Globally, CSOM affects between 65 to 330 million people, with 60% experiencing significant hearing impairment. It causes about 28,000 deaths annually and results in over 2 million Disability-Adjusted Life Years (DALYs). The incidence is notably higher in developing countries due to factors like poor socio-economic conditions, inadequate nutrition, and lack of health education. In India, the prevalence is 46 per thousand in rural areas and 16 per thousand in urban areas, making it a major cause of hearing impairment in rural populations. Effective management of CSOM often involves surgical intervention, particularly mastoidectomy combined with tympanoplasty. This approach aims to remove infected tissue, achieve a dry and healthy ear, and improve hearing outcomes. The success of tympanic membrane reconstruction largely depends on addressing any mastoid disease. The prevalence of CSOM is linked to poor living conditions, and surgical treatments can help reduce disease burden and improve quality of life by preventing recurrent infections and promoting hearing restoration. |