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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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