| CTRI Number |
CTRI/2025/10/095864 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to determine the success and complication rate in mastoid surgeries |
|
Scientific Title of Study
|
Prospective study on outcomes of cholesteatoma surgery in a tertiary care center |
| 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 Moumita Barik |
| Designation |
Junior resident |
| Affiliation |
Aiims, new delhi |
| Address |
Dept of Otorhinolaryngology and Head and Neck Surgery, 4th floor, main building, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
7827877359 |
| Fax |
|
| Email |
barikmoumita08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Sagar |
| Designation |
Assistant professor |
| Affiliation |
Aiims, new delhi |
| Address |
Dept of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818979820 |
| Fax |
|
| Email |
poonamsgr.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moumita Barik |
| Designation |
Junior resident |
| Affiliation |
Aiims, new delhi |
| Address |
Dept of Otorhinolaryngology and Head and Neck Surgery, 4th floor, main building, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
7827877359 |
| Fax |
|
| Email |
barikmoumita08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences New Delhi |
| Address |
All India Institute of Medical Sciences, New Delhi , India 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 Moumita |
All India Institute of Medical Sciences, New Delhi |
Dept of Otorhinolaryngology and Head and Neck Surgery, 4th floor, Main Building, All India Institute of Medical Sciences, New Delhi, India 110029
New Delhi
DELHI |
7827877359
barikmoumita08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, aiims new delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H719||Unspecified cholesteatoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18-65 yrs of all genders diagnosed with acquired cholesteatomatous disease.
Patients undergoing primary cholesteatoma surgery.
Patients willing to provide written informed consent and comply with follow-up protocol. |
|
| ExclusionCriteria |
| Details |
Patients not willing to consent
Patients with uncontrolled comorbidities affecting healing and surgical outcomes
patients undergoing revision cholesteatoma surgery
patients unfit for surgery under GA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery
To compare pre & post surgery hearing outcomes at six months. |
To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery
To compare pre & post surgery hearing outcomes at six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine radiologic correlation of disease extent with intraoperative findings
to compare the quality of life pre and post surgery using Chronic Ear Survey scale
To study socioeconomic (by modified kuppuswamy scale) and epidemiologic profile of the patient
To determine rate/ incidence of complications. |
Day of surgery, 1 month, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/10/2025 |
| 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="6"
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
|
Patients aged 18-65 yrs and all genders diagnosed with acquired cholesteatoma and planned for cholesteatoma surgery will be recruited. Detailed history taking and clinical examination will be done. Patients will undergo Pure Tone Audiometry (PTA) and HRCT Temporal Bone. Surgery as per extent of disease will be performed. Intraoperatively correlated with radiological findings. Chronic ear Survey questionairre to be done at preop and at 6 months to compare the quality of life before and after surgery Follow up on 1 month, 3 month and 6 months for clinical examination to assess for complcations PTA to be done preoperatively and at 6 months to compare improvement in hearing. |