| CTRI Number |
CTRI/2024/10/075634 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison Of Preoperative HRCT Findings With Intraoperative Surgical Findings |
|
Scientific Title of Study
|
The comparison of radiological and intraoperative finding in patients of active squamosal disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR P K RATHORE |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 403 BLT BLOCK Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
07982832961 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P K RATHORE |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 403 BLT BLOCK Maulana Azad Medical College
DELHI
110002
India |
| Phone |
07982832961 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR P K RATHORE |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 403 BLT BLOCK Maulana Azad Medical College
DELHI
110002
India |
| Phone |
07982832961 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College , India , Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad MEdical College |
| Address |
Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 |
| 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 Devesh Nogia |
Maulana Azad Medical College |
Maulana Azad Medical College,
new Delhi , Department Of ENT , room number 302
Central
DELHI |
7982832961
deveshnogia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with active squamosal disease
|
|
| ExclusionCriteria |
| Details |
Post operative / Revision procedures , previous history of ear surgeries , congenital anomalies . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To compare HRCT Temporal bone findings with intra-operative findings .
2 To analyze complication in Active squamosal disease .
|
intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Analyze complication in COM [ Active squamosal disease]
-Efficacy of HRCT in assessing Extent of disease.
|
intraoperative
|
|
|
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)
|
08/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/11/2024 |
| 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 Yet Recruiting |
| 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 study will be conducted after approval from the Institute’s ethical committee. • The patients coming in the outpatient department of ENT to Lok Nayak Hospital and associated Maulana Azad Medical College will be included in the study. • All patients with COM[Active squamosal disease] will be included . • All patients will be explained the standard protocol of treating Active squamosal disease . Informed consent in vernacular language will be obtained in every case. • The demographic and clinical details of all subjects such as age, sex and relevant clinical history and findings will be recorded on a predesigned proforma. • The patients will undergo thorough clinical examination and then will be sent for HRCT Temporal bone to look for the radiological features. • The patient will undergo routine management of the chronic Otitis Media as per the standard guidelines which will include surgical intervention when indicated. • The data will be analyzed to correlate the findings on Radiology and surgical basis. |