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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [patel.abhishek13@gmail.com].
- 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.
- 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 |