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CTRI Number  CTRI/2023/08/056627 [Registered on: 18/08/2023] Trial Registered Prospectively
Last Modified On: 17/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study analyze the effect of addition of endoscope to microscopic tympanomastoid exploration in case of Chronic Otitis Media (Squamous) disease and evaluate its outcome  
Scientific Title of Study   A study to evaluate effect after addition of endoscope to microscopic tympanomastoid exploration for chronic otitis media squamous (active)- a randomised control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Patel 
Designation  Resident ENT 
Affiliation  Armed Forces Medical College 
Address  Dept of Otorhinolaryngology and Head and Neck Surgery, AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  07435888753  
Fax    
Email  patel.abhishek13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lt Col (Dr) Kamalpreet Singh 
Designation  Associate Professor 
Affiliation  Armed Forces Medical College 
Address  Dept of Otorhinolaryngology and Head and Neck Surgery, AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  9341709008  
Fax    
Email  kpsingh_81@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Abhishek Patel 
Designation  Resident ENT 
Affiliation  Armed Forces Medical College 
Address  Dept of Otorhinolaryngology and Head and Neck Surgery, AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  07435888753  
Fax    
Email  patel.abhishek13@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Pune 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Dept of Otorhinolaryngology and Head and Neck Surgery, AFMC Pune 
Type of Sponsor  Research institution and hospital 
 
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 
Abhishek Patel  COMMAND HOSPITAL SOUTHERN COMMAND, PUNE  Dept of Otorhinolaryngology and Head and Neck Surgery, AFMC Pune - 411040
Pune
MAHARASHTRA 
07435888753

patel.abhishek13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H719||Unspecified cholesteatoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A- Tympanomastoid exploration with microscope  Patients diagnosed as a case of Chronic Otitis Media Squamous (active) with intact posterior canal wall, planned for tympanomastoid exploration with microscope 
Intervention  Group B- Tympanomastoid exploration with microscope and intra operative endoscope assistance   Patients diagnosed as a case of Chronic Otitis Media Squamous (active) with intact posterior canal wall, planned for tympanomastoid exploration with microscope and endoscope assistance will be used intraoperatively to asses the effect of its addition in terms of visualization of difficult areas, disease clearance and preservation of normal anatomy 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All consenting patients with Chronic Otitis Media Squamous (active) with involvement of more than 1 site as per STAM CO classification 
 
ExclusionCriteria 
Details  a. Patients with Chronic Otitis Media Squamous (Inactive)
b. Patients with complications of Chronic Otitis Media Squamous
c. Patients with posterior canal wall erosion
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy  Intraoperative 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate functional outcomes in terms of disease progression and audiological results  3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/08/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [patel.abhishek13@gmail.com].

  6. For how long will this data be available start date provided 08-03-2025 and end date provided 08-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Background-

The surgical procedure for Chronic Otitis Media Squamous (Active) can either be a canal wall up (CWU) or a canal wall down (CWD) procedure. Both procedures have their advantages and disadvantages. Disease eradication being the primary aim of the surgery, its important to achieve complete clearance of the disease from the middle ear and mastoid. The hidden/ difficult to reach areas include the sinus tympani, deep tip cells, sinodural angle cells and deep supratubal recess. Literature states, intraoperative residual cholesteatoma rates of 13% in CWU mastoidectomy operation and 11.8% in CWD mastoidectomy operation when using microscope.

In contemporary practice, most otologists favour CWU surgery as far as possible in order to preserve normal anatomy alongwith disease clearance. With the advent of modern technology with better illumination, better optics and better magnification this has been possible to a large extent.

 Traditionally the otomicroscope has been used for these procedures, however with the advent of endoscopes it has been demonstrated that previously hidden/ difficult areas have become more accessible and it’s the way ahead for these surgeries. The endoscope has been used for grommet insertion, tympanoplasty and few cases of mastoid surgeries. The proponents of endoscope state its advantage of better visualization and better maneuverability in comparison to otomicroscope. However, the exact role of an endoscope in mastoidectomy has not been established.

This study aims to study the effect of addition of endoscope to traditional microscopic surgery in our subset of patients. 

Purpose-

Primary Objective - To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy

Secondary Objective- To Evaluate the functional outcomes of in terms of disease progression and audiological outcomes 

 
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