| CTRI Number |
CTRI/2020/11/029065 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPLICATIONS OF INFECTED EAR |
|
Scientific Title of Study
|
A STUDY OF COMPLICATIONS OF CHRONIC SUPPURATIVE OTITIS MEDIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Senbagadevi S |
| Designation |
2nd YEAR ENT RESIDENT |
| Affiliation |
Sir.T. Hospital and Government medical College , Bhavnagar |
| Address |
ENT department,
Room number-302, PG-2 Hostel, Sir T Hospital,Bhavnagar.
Ent department, sir.t hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8098024181 |
| Fax |
|
| Email |
drsenbasiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Jha |
| Designation |
Professor And HOD of ENT department |
| Affiliation |
ENT Department ,Sir.T. Hospital and Government medical College , Bhavnagar |
| Address |
ENT Department, Sir T Hospital, GMC, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Andalib Daymakumar |
| Designation |
ENT Resident |
| Affiliation |
Resident of ENT, Sir.T. Hospital and Government medical College , Bhavnagar |
| Address |
ENT DEPARTMENT,
Room number-703, PG-3 Hostel, Sir T hospital, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8460514913 |
| Fax |
|
| Email |
dayma_andalib@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Otorinolaryngology, Government Medical College, Sir T Hospital, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of ENT |
| Address |
Department of Otorhinolaryngology, Goverment medical college, Sir T Hospital, Bhavnagar |
| 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 Senbagadevi S |
Sir T Hospital, Bhavnagar |
Department of ENT, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT |
8098024181
drsenbasiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB, GMC, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will give positive consent for the study.
All patients with extra and intra cranial complications CSOM who were clinically and radiologically diagnosed will be included.
Patients of all age groups and both sexes will be included.
Both cholesteatomatous and non cholesteatomatous ears will be included.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early diagnosis of different complications of CSOM and its timely management |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Age, sex , locality, religion, socio economic status , laterality, associated factors of different complications of CSOM |
15 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ØCHRONIC
SUPPURATIVE OTITIS MEDIA (CSOM) is one of the most common disease entities
encountered in otolaryngology practice.
ØChronic
suppurative otitis
media is described as chronic inflammation of middle ear cleft associated with
perforation of tympanic membrane and otorrhoea.
ØThough
there is general decline in incidence of complications due to appropriate use
of antibiotics they are still frequently seen in our country.
ØCAUSES:
Ø Due to development of multidrug resistent
pathogens
Ø Poor socio economic conditions
Ø Lack of education and awareness
Ø Lack of availability of trained
specialist. |