| CTRI Number |
CTRI/2022/06/043529 [Registered on: 28/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY OF FOREIGN BODY IN EAR NOSE OR THROAT |
|
Scientific Title of Study
|
CLINICAL PROFILE OF DIFFERENT TYPE OF FOREIGN BODY IN EAR NOSE THROAT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Kumar Meena |
| Designation |
first year ENT resident |
| Affiliation |
govt.medical college,bhavnagar |
| Address |
ENT Department 24,PG Hostel 1,
Sir T hospital campus,
Jail road,
Bhavnagar 364001(Gujarat)
Bhavnagar
GUJARAT
364001
India |
| Phone |
7615023002 |
| Fax |
0278-2511511 |
| Email |
manojkm970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil G Jha |
| Designation |
Head of Department in Otorhinolaryngology |
| Affiliation |
govt.medical college,bhavnagar |
| Address |
Department of Otorhinolaryngology and Head and Neck Surgery, Sir T Hospital, Jail road, BHAVNAGAR.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Chawda |
| Designation |
first year ENT resident |
| Affiliation |
|
| Address |
ENT Department 501 PG Hostel 3,
Sir T hospital campus,
Jail road ,
Bhavnagar 364001(Gujarat)
Bhavnagar
GUJARAT
364001
India |
| Phone |
8980492784 |
| Fax |
|
| Email |
uditchawda18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology, Sir T Hospital, Government Medical College ,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology |
| Address |
Sir T Hospital , Jail road , 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 Manoj Kumar Meena |
Department of Otorhinolaryngology and Head and Neck Surgery |
ENT Department bedside cancer care center Sir T Hospital, Jail road, Bhavnagar.
GUJARAT
Bhavnagar
GUJARAT |
7615023002
manojkm970@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T169||Foreign body in ear, unspecified ear, (2) ICD-10 Condition: T179||Foreign body in respiratory tract,part unspecified, (3) ICD-10 Condition: T180||Foreign body in mouth, (4) ICD-10 Condition: T181||Foreign body in esophagus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who presented with foreign body in ear nose and throat.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1Different type of foreign body in ear nose and throat
ï‚— Complains of patients due to foreign body in ear nose throat
2.Mode of treatment
3.age wise distribution
4.Sex wise distribution
5 clinical presentation of foreign body in ear nose throat
|
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Occupation of parents
2.Education of Parents
3.Site of residency
|
5 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/06/2022 |
| 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
|
noy yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My dissertation is about clinical study and management of various foreign body in ear , nose ,
throat.
As we all know that foreign body ingestion and insertion is a most common type of presenting
emergency in OPD setup and my study is to observe various aspect of that.
from this study I will analyse , 1 different type of foreign body in ear nose or throat 2. complication of different type of foreign in ent. 3 age wise distribution 4 mode of management |