| CTRI Number |
CTRI/2017/09/009612 [Registered on: 04/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Observational study of inherited variations in ear nose and throat, at tertiary care hospital Bhavnagar |
|
Scientific Title of Study
|
Observation of congenital anomalies in otorhinolaryngology at tertiary care hospital Bhavnagar |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jignabahen Bharatbhai Savani |
| Designation |
First year resident in ENT department GMC Bhavnagar |
| Affiliation |
GMC Bhavnagar |
| Address |
Sir T. Hospital , government medical college bhavnagar 364001
Sir T. hospital government medical college Bhavnagar 364002
Bhavnagar
GUJARAT
364001
India |
| Phone |
7283903819 |
| Fax |
|
| Email |
j.b.savani2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagirathsinh Parmar |
| Designation |
Assistant Professor in ENT department GMC BHAVANAGAR |
| Affiliation |
GMC Bhavnagar |
| Address |
ENT department , sir T. hospital Bhavnagar 364001
ENT department , sir T. hospital Bhavnagar 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408688505 |
| Fax |
|
| Email |
drbhagirath89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jignabahen Bharatbhai Savani |
| Designation |
First year resident in ENT department GMC Bhavnagar |
| Affiliation |
GMC Bhavnagar |
| Address |
Room no. 602 doctor quators D block Sir T. hospital 364001
Room no. 602 doctor quators D block Sir T. hospital 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
7283903819 |
| Fax |
|
| Email |
j.b.savani2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir T. Hospital Bhavnagar
Gujrat , India 364001
|
|
|
Primary Sponsor
|
| Name |
ENT Department GMC Bhavnagar |
| Address |
Sir T. Hospital Bhavnagar , Gujarat , India 364001 |
| Type of Sponsor |
Government medical college |
|
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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 Jignabahen Bhavnagar Savani |
Sir T. Hospital Bhavnagar |
Sir T. Hospital Bhavnagar364001
Bhavnagar
GUJARAT |
7283903819
j.b.savani2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB)/[Human Ethics Committee (HEC)] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient with otorhinolaryngological congenital anomalies, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 ] Subject who gave positive informed and written consent.
2 ] Subject with congenital anomalies in ear , nose , oral cavity throat pharynx, trachea , oesophagus , neck , cranial valt and Face.
|
|
| ExclusionCriteria |
| Details |
1 ] Subject who didn’t give positive informed and written consent.
2 ] Subject who didn’t have congenital anomaly related to otorhinolaryngology.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aim of study is observe the otolaryngological congenital anomalies and to get an overview incidence and presentation in community. |
July 2016 to July 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Children with ENT anomaly can managed accordingly. |
July 2016 to July 2018 |
|
|
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)
|
06/07/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Department of Otorhinolaryngology Govt. Medical College, Bhavnagar 364001.
Title of the Project:“Observational Study of congenital anomalies in Otorhinolaryngology at tertiary care hospital at bhavnagar" Principal investigator and Co-investigators
Principal investigator: Dr.Jignabahen B. Savani 1st year resident ENT Co. Principal investigater:Dr.Vikas Sinha Professor & Superitendent ENT Co investigator :i). Dr. Sushil G. Jha H.O.D & professor ENT Co investigator : ii). Dr. Bhagirath Parmar assistant professor ENT (Give detailed report of the project with summarized methodology, results, discussion and conclusions.)
Many children will present with otorhinolaryngological congenital abnormalities and it is important that he or she should be familiar with characteristics afflicted with number of this anomalies. This study is conducted with intension to find out such subjects and to councel them and their parents about curability , rehabilitation , other organ involvement and provide education about management . Aim of therapeutic interventions should be to give if not a normal at least near normal appearance and functional profile. Together with management of child , the parents should be counselled advised allaying their apprehension and fears and outlining a realistic expectancy regarding cure.
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