| CTRI Number |
CTRI/2021/09/036561 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Endoscopic And Radiological Study Of Hidden Area In Ear |
|
Scientific Title of Study
|
Endoscopic And Radiological Correlation Of Anatomy Of Sinus Tympani In Squamous Type Of Chronic 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 |
Sakshi Negi |
| Designation |
MS Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of ENT and Head Neck Surgery, B L Taneja Block, Maulana Azad Medical College, Central Delhi
Central
DELHI
110002
India |
| Phone |
8742942776 |
| Fax |
|
| Email |
sakshinegi9041@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ishwar Singh |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of ENT and Head Neck Surgery, B L Taneja Block, Maulana Azad Medical College, Central Delhi
Central
DELHI
110002
India |
| Phone |
9953863099 |
| Fax |
|
| Email |
drisingh62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishwar Singh |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of ENT and Head Neck Surgery, B L Taneja Block, Maulana Azad Medical College, Central Delhi
Central
DELHI
110002
India |
| Phone |
9953863099 |
| Fax |
|
| Email |
drisingh62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Dept Of Planning, Academic Block Maulana Azad Medical College |
| 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 |
| Sakshi Negi |
Lok Nayak Hospital |
Department OF ENT
Department Of Radio diagnosis
Central
DELHI |
8742942776
sakshinegi9041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (2) ICD-10 Condition: H673||Otitis media in diseases classified elsewhere, bilateral, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Surgery and Radio diagnosis |
Endoscopic Mastoid Exploration And HRCT Temporal bone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients clinically diagnosed with squamosal chronic otitis media.
2. Age group >18 years
|
|
| ExclusionCriteria |
| Details |
1. COM (mucosal type)
2. Congenital cholesteatoma
3. Revision ear surgery
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the endoscopic and radiological anatomy of sinus tympani in patient diagnosed with squamosal COM. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Any |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/09/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshinegi9041@gmail.com].
- For how long will this data be available start date provided 24-05-2023 and end date provided 29-02-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Not Any
|
|
Brief Summary
|
Sinus Tympani is one of the hidden area in middle ear where cholesteatoma, retraction pockets and granulation tissue is common.In our study we aim to evaluate endoscopic anatomy of sinus tympani and do endoscopic mastoid exploration in the patients presenting with squamosal COM
|