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CTRI Number  CTRI/2024/04/066041 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A trial which randomly assign patients needing stapes surgery to either endoscopic or microscopic procedures to see which one yields better results in terms of hearing improvement, complications, surgery duration, post-operative pain, and patient satisfaction  
Scientific Title of Study   A Randomized Control Trial to compare the outcomes of endoscopic and microscopic stapes surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thalhath A Salam 
Designation  Junior Resident  
Affiliation  AIIMS New Delhi 
Address  Room no 4057 Department of Otorhinolaryngology and head and neck surgery 4th floor, Academic block AIIMS, Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9818801077  
Fax    
Email  dr.thalhathasalam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Rakesh Kumar 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 4053 Department of Otorhinolaryngology and head and neck surgery 4th floor, Academic block AIIMS, Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9868397461  
Fax    
Email  winirk@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Thalhath A Salam 
Designation  Junior Resident  
Affiliation  AIIMS New Delhi 
Address  Room no 4057 Department of Otorhinolaryngology and head and neck surgery 4th floor, Academic block AIIMS, Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  8075992849  
Fax    
Email  dr.thalhathasalam@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Ansari Nagar, New Delhi India PIN: 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi 110029 
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 
Thalhath A Salam  All India Institute of Medical Sciences  Room no 4057 Department of Otorhinolaryngology and head and neck surgery 4th floor, Academic block AIIMS Ansari Nagar, New Delhi 110029
South
DELHI 		 9818801077

dr.thalhathasalam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee for post graduate research, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H743||Other acquired abnormalities of ear ossicles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed with otosclerosis based on clinical history, examination and audiological assessment and opting for surgery.
Patient with normal otoscopy findings
Patient aged between 18 - 50 years
Absent history of past middle ear infection diseases/past ear surgeries
Patients undergoing stapes surgery under Local Anesthesia
Only primary cases are included
Patient willing to give written informed consent for surgery and to be part of the study
 
 
ExclusionCriteria 
Details  Patients with extreme of ages less than 18 years of age and greater than 50 years of age
Patients with other causes of hearing loss.
Patients with external ear and other middle ear pathologies.
Patients with comorbidities deeming them unfit for local anesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the outcomes of endoscopic and microscopic stapes surgery in terms of post op hearing improvement.
To compare the various intraoperative and postoperative complications of endoscopic and microscopic stapes surgery
 		 At pack removal (post op day 7), after 1 month and 3 months post surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the visualization of various middle ear structures in order to understand the easiness of stapes surgery between endoscopic and microscopic stapes surgery in a trainee point of view.  1 day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   29/04/2024 
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="9"
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 - 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 - Researchers who provide a methodologically sound proposal.

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

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included dr.thalhathasalam@gmail.com).

  6. For how long will this data be available start date provided 15-03-2026 and end date provided 15-03-2029?
    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   Otosclerosis is a hereditary localized disease of the bone formed from the otic capsule characterized by alternating phases of bone formation and resorption. Treatment options for otosclerosis include medical management (NaF), hearing aids and surgery. While hearing aids can effectively manage the condition in its early stages, surgery may become necessary for a more definitive solution. Traditionally, stapedotomy is performed using an operating microscope and is the established treatment for otosclerosis. However, with the introduction of endoscopes, an increasing number of medical centers are performing endoscopic stapedotomy.

The primary aim of my study is to

  1. To compare the outcomes of  endoscopic  and microscopic stapes surgery in terms of post op hearing improvement.

  1. To compare the various intraoperative and postoperative complications of  endoscopic  and microscopic stapes surgery

The secondary aim of the study is to assess the visualization of various middle ear structures in order to understand the easiness of stapes surgery between endoscopic and microscopic stapes surgery in a trainee point of view.

When a patient is following up in the department of Otorhinolaryngology-Head and Neck Surgery and planned for surgery, his consent will be taken to participate in the study. After his consent is taken, we will ask them a set of questions, which includes their demographics, personal, family history and clinical history. After assessing his medical history and performing a clinical examination, he will be randomized to either microscopic stapes surgery group or endoscopic stapes surgery group and undergo stapes surgery . The outcome and complications of their surgery will be assessed and studied.


 
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