| CTRI Number |
CTRI/2026/03/105394 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different surgical approaches for ear (mastoid) surgery and their effect on patients’ quality of life |
|
Scientific Title of Study
|
A randomised controlled trial comparing quality of life outcomes following endaural inside out mastoidectomy and postaural outside in mastoidectomy approaches |
| 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 Khushi Gupta |
| Designation |
MS Student |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room 175, Department of ENT and Head and Neck Surgery, All India Institute of Medical Sciences (AIIMS) Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9136047331 |
| Fax |
|
| Email |
kgupta78910@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saurav Sarkar |
| Designation |
Additional Professor and Guide |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Room 175, Department of ENT and Head and Neck Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9830315933 |
| Fax |
|
| Email |
ent_saurav@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Khushi Gupta |
| Designation |
MS student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 175, Department of ENT and Head and Neck Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9136047331 |
| Fax |
|
| Email |
kgupta78910@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha, 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha, 751019 |
| 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 Khushi Gupta |
AIIMS BHUBANESWAR |
Department of ENT and head and neck surgery, AIIMS Bhubaneswar Khordha ORISSA |
9136047331
kgupta78910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHUBANESWAR INSTITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inside out Mastoidectomy |
To follow the disease from inside during mastoidectomy. Total duration of trial - 2 years |
| Comparator Agent |
Outside in mastoidectomy |
To follow the disease from outside during mastoidectomy. Total duration of trial - 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Adults aged more than 18 years 2)Diagnosed COM requiring canal wall down mastoidectomy |
|
| ExclusionCriteria |
| Details |
1) Age less than 18 years 2) Patient not fit for surgery 3) Prior mastoid surgery on the same ear 4) Complicated COM 5) Unwillingness to consent |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life outcomes measured using Modified Chronic Otitis Media Questionnaire (Modified COMQ) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative cosmesis |
3 months |
| Disease control |
3 months |
| Hearing outcomes |
3 months |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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)
|
Not Applicable |
| 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
|
Both inside-out mastoidectomy and outside-in mastoidectomy techniques are established for treating chronic middle ear disease, but they differ in their extent of disease clearance, technical demand, and preservation of healthy structures. While Inside-out mastoidectomy is more targeted, often preserving more healthy bone and soft tissue, potentially resulting in improved post-operative cosmesis, on the other hand, Outside-in mastoidectomy provides systematic and extensive disease clearance, which may, however, result in greater changes to post-operative ear anatomy, which could negatively impact cosmesis. Assessment of pain, hearing improvement, and disease control are central to understanding the overall benefit of each method, but quality of life and patient satisfaction incorporating cosmesis are often underreported in literature comparing these techniques. By evaluating these outcomes side-by-side, we may highlight the need for considering both clinical objectives and patient-perceived benefits when planning a mastoidectomy surgery, paving the way for a more holistic treatment of chronic middle ear disease |