| CTRI Number |
CTRI/2024/09/074205 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors affecting the outcome of tympanoplasty |
|
Scientific Title of Study
|
A prospective audit of tympanoplasty and evaluation of factors affecting the outcome. |
| 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. Ashish Kumar Arya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4075, Department of ENT, Old teaching block, All India Institute of Medical Sciences, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
8442084807 |
| Fax |
|
| Email |
ashishkumararya02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Alok Thakar |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 4056, Department of Otorhinolaryngology and Head and Neck Surgery, Old Teaching Block, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
9999755916 |
| Fax |
|
| Email |
drathakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ashish Kumar Arya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4075, Department of Otorhinolaryngology, All India Institue of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8442084807 |
| Fax |
|
| Email |
ashishkumararya02@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 |
| 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 Ashish Kumar Arya |
All India Institute of Medical Sciences, New Delhi |
Department of Otorhinolaryngology,Room no. 4057, ENT office, Teaching Block, AIIMS, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI |
08442084807
ashishkumararya02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Delhi Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with mucosal chronic otitis media undergoing type-1 tympanoplasty |
|
| ExclusionCriteria |
| Details |
1. Patients operated by surgeons with less than 18 months experience
2. patients with Sensorineural hearing loss
3. complicated CSOM
4. traumatic perforation
5. revision surgery |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the rate of perforation closure and remission of ear discharge after tympanoplasty at 3 months
2. to assess the hearing change post surgery at 3 months
3. to assesss the factors affecting the above mentioned objectives |
At 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the rate of perforation closure and remission of ear discharge after type 1 tympanoplasty at 6 and 12 months
2. to assess the hearing change post surgery at 6 and 12 months
|
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/10/2024 |
| 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 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
|
Given the heterogeneity in literature regarding the factors influencing
outcome in tympanoplasty result, we intend to analyze our results of
tympanoplasty, prospectively in adult patients. Through this study, we would identify
and categorize comprehensively all possible factors and determine the degree of
influence they have on outcomes.
This can help in improved
counselling of the patients preoperatively regarding the prognosis of surgical
repair of tympanic membrane defects. |