| CTRI Number |
CTRI/2023/03/050883 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
TO COMPARE THE OUTCOME OF TYPE-1 TYMPANOPLASTY IN CASES OF CHRONIC OTITIS MEDIA (INACTIVE MUCOSAL DISEASES) IN PATIENTS WITH NORMAL EUSTACHIAN TUBE FUNCTION , PARTIAL DYSFUNCTION AND GROSS DYSFUNCTIN |
|
Scientific Title of Study
|
CORRELATION OF EUSTACHIAN TUBE FUNCTION WITH THE OUTCOME OF TYPE-1 TYMPANOPLASTY IN CASES OF CHRONIC OTITIS MEDIA (INACTIVE MUCOSAL DISEASES) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rinchen Angmo |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
3rd Floor Department of ENT and Head and Neck surgery
BL Taneja Block
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7838118994 |
| Fax |
|
| Email |
rinchenangmo733@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HC Taneja |
| Designation |
Director Professor ENT |
| Affiliation |
Maulana Azad Medical College |
| Address |
3rd Floor Department of ENT and Head and Neck surgery
BL Taneja Block
Maulana Azad Medical College and associated Lok Nayak Hospital
3rd Floor Department of ENT and Head and Neck surgery
BL Taneja Block
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9868399555 |
| Fax |
|
| Email |
taneja_hc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rinchen Angmo |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
3rd Floor Department of ENT and Head and Neck Surgery
BL Taneja Block
Maulana Azad Medical College
3rd Floor Department of ENT and Head and Neck Surgery
BL Taneja Block
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7838118994 |
| Fax |
|
| Email |
rinchenangmo733@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT
Maulana Azad Medical College and associated Lok Nayak Hospital. Bahadur Shah Zafar Marg .New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak hospital |
| Address |
JLN Marg New 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 |
| Rinchen Angmo |
Lok Nayak Hospital |
Depart of ENT and Head and Neck Surgery . 3rd floor BL Taneja Block
Central
DELHI |
7838118994
rinchenangmo733@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H698||Other specified disorders of Eustachian tube, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic Otitis Media Inactive Mucosal Disease |
|
| ExclusionCriteria |
| Details |
Active nasopharyngeal or sinus infection
Active Ear infections
Chronic Otitis Media squamosal type
any tumor or mass in nasopharynx
chronic nasal pathology
cleft palate or velopharyngeal insufficiency
uncontrolled systemic comorbidities
revision ear surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Graft uptake seen on oto-endoscope
in patients of chronic otitis media inactive mucosal disease with normal function, partial dysfunction and gross dysfunction of Eustachian tube |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Air Bone Gap by audiometry in patients with chronic otitis median inactive mucosal disease with normal function partial dysfunction and gross dysfunction of Eustachian tube |
3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/03/2023 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
We are taking patients with Chronic otitis media inactive mucosal disease and performing Eustachian tube function tests on all of them namely Methylene blue test and saccharine test. Based on these tests we’re diving the patients in 3 groups A - Normal Eustachian tube function ( methylene blue clearance time < 10mins and saccharine perception time <20 minutes ) B- partial dysfunction ( methylene blue clearance time of 10 -20 mins, saccharine test 20-45 mins) C - gross dysfunction ( methylene blue test >30 mins , saccharin Test >45 minutes) We then compare the outcome of type 1 tympanoplasty between the patients of the above three groups on the basis of graft uptake and Improvement in post op pure tone audiometer |