FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close