| CTRI Number |
CTRI/2025/10/096301 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective study comparing the preoperative CT temporal bone findings and intra operative findings in sqaumosal chronic suppurative otitis media in patients undergoing mastoidectomy |
|
Scientific Title of Study
|
A prospective study correlating the preoperative HRCT temporal bone findings and intra operative findings in squamosal type chronic suppurative otitis media , in
patients undergoing mastoidectomy |
| 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 Sharvari Rane |
| Designation |
junior resident |
| Affiliation |
kasturba hospital, manipal |
| Address |
ENT department , 4th floor,
ENT department , 4th floor,
Udupi
KARNATAKA
576104
India |
| Phone |
9099159609 |
| Fax |
|
| Email |
sharrne2408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROHIT SINGH |
| Designation |
junior resident |
| Affiliation |
kasturba hospital, manipal |
| Address |
ENT DEPARTMENT, 4TH FLOOR, ENT OPD
ENT DEPARTMENT, 4TH FLOOR, ENT OPD
Udupi
KARNATAKA
576104
India |
| Phone |
9099159609 |
| Fax |
|
| Email |
rohit.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharvari Rane |
| Designation |
junior resident |
| Affiliation |
kasturba hospital, manipal |
| Address |
ent department, room 7, 4th floor
ent department, room 7, 4th floor
Udupi
KARNATAKA
576104
India |
| Phone |
9099159609 |
| Fax |
|
| Email |
sharrne2408@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
kasturba hopital manipal |
| Address |
304-A block, 3rd floor, hayagreeva nagar , manipal, karnataka |
| Type of Sponsor |
Private 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 sharvari rane |
kasturba medical college , manipal |
27/c , nandigram society 2 , sindhwai mata road , manjalpur , vadodara
Udupi
KARNATAKA |
09099159609
sharrne2408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H712||Cholesteatoma of mastoid, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-1.All Patients of any gender and all age groups -2.diagnosed with squamosal type of chronic suppurative otitis media
-3. sqaumosal type
-4.who are candidates for mastoidectomy |
|
| ExclusionCriteria |
| Details |
Patients in whom CT scan is contraindicated
Patients with mucosal type of CSOM
Patients with :
1.previous ear surgery
2.congenital ear anomalies,
3.systemic diseases affecting ear , like granulomatous diseases
4.malignancies of temporal bone and skull base(like vestibular schwanoma , facial nerve hemangioma,
paraganglioma ,etc) ,
5.those with history of head and neck radiation therapy
6.Patients unfit for surgery/anaesthesia
7.Patients not giving consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the correlation of HRCT temporal bone findings with intra operative findings in a case
of chronic suppurative otitis media (squamousal type) |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study efficacy of HRCT in determining anatomical anomalies & intraoperative extent of cholesteatoma disease |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2026 |
| 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)
|
Open to Recruitment |
| 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
|
A prospective study correlating the preoperative high resolution computed tomography -temporal bone findings and intra operative findings in squamous type chronic suppurative otitis media , in patients undergoing canal wall up and down mastoidectomy which aims To study the correlation of HRCT temporal bone findings with intra operative findings in a case of chronic suppurative otitis media (squamous type) |