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CTRI Number  CTRI/2025/02/081149 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare the Result of Placing the Graft on the Inner side and the Outer side of the Bone in the Ear in Ear Drum Perforation Surgeries. 
Scientific Title of Study   A Study Comparing the outcomes of Graft Placement Medial and Lateral to the Handle of Malleus in Type 1 Tympanoplasty Underlay Technique. 
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 KRITIKA AGRAWAL 
Designation  Post Graduate Resident 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital 
Address  Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9997451659  
Fax    
Email  kritikasinghaljpr10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poornima S Bhat 
Designation  Associate Professor 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital 
Address  Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  7867834401  
Fax    
Email  Poornimasbhat86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saquib Reyaz Khan 
Designation  Associate Professor 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital 
Address  Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  7275710184  
Fax    
Email  Saquibkhan366@gmail.com  
 
Source of Monetary or Material Support  
Varun Arjun medical College and Rohilkhand Hospital, Lucknow Road, Banthra , Shahjahanpur, 242307, India 
 
Primary Sponsor  
Name  Dr. Kritika Agrawal 
Address  Varun Arjun Medical College, Banthra, Shahjahanpur, India, 242307 
Type of Sponsor  Other [SELF] 
 
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 Kritika agrawal  Rohilkhanad Hospital, Banthra, Shahjahanpur  Roon no 100 Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH 
9997451659

kritikasinghaljpr10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VAMC  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 
Comparator Agent  graft placed over the handle of malleus  patient undergoing type 1 tympanoplasty where graft will be placed over the handle of malleus which will be done for 1 year 
Comparator Agent  graft placed under the handle of malleus  patient undergoing type 1 tympanoplasty where graft will be placed under the handle of malleus which will be done for 1 year 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient admitted and willing for procedure
Patients with inactive chronic otitis media tubotympanic disease.
Patients with isolated conductive hearing loss with an Air bone gap of less than 45dB.
Dry ear for atleast 6 weeks
Small or medium sized central perforation in tympanic membrane
 
 
ExclusionCriteria 
Details  Patients with recurrent chronic otitis media after previous surgery.
Patient with ossicular disruption.
Patients with complications of chronic otitis media.
Patients with uncontrolled co-morbidities like diabetes mellitus, systemic hypertension, and Bronchial asthma, tuberculosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the graft uptake rate in both techniques  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hearing improvement in both techniques.  1 year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/02/2025 
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="0"
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 - NO
Brief Summary  

The study "a study comparing the outcomes of graft placement medial and lateral to the handle of malleus in type 1 tympanoplasty underlay technique" will be conducted in the department of otorhinolaryngology, varun arjun medical college, and rohilkhand hospital, banthra, shahjahanpur, uttar pradesh.

 

a. study setting and participants

the research focuses on patients with tympanic membrane perforations due to chronic otitis media (com) of the mucosal type, attending the ent outpatient clinic of the aforementioned institution. the inclusion and exclusion criteria ensure that eligible participants are between 12 and 60 years old, present isolated conductive hearing loss, and exhibit inactive com with specific tympanic perforations. patients with recurrent com, ossicular disruption, or uncontrolled systemic conditions are excluded.

 

b. objectives

1. evaluate graft uptake success rates for medial versus lateral placement of temporalis fascia.

2. compare hearing improvement post-surgery.

3. assess complications associated with each grafting technique.

 

c. methodology

design: prospective randomized controlled trial.

duration: april 2024 to september 2025.

sample size: 40 patients (20 per group), randomly assigned to either medial or lateral graft placement groups.

procedures: all patients undergo type 1 tympanoplasty using a postaural approach with temporalis fascia grafting, followed by consistent follow-ups (up to six months post-surgery).

outcome measures: graft uptake, improvement in air-bone gap via pure tone audiometry, and incidence of post-op complications.

 

d. data analysis

spss software will be used to analyze categorical and quantitative variables. statistical significance is determined at a p-value < 0.05.

 

e. significance

the findings aim to guide surgeons in optimizing graft placement for better hearing outcomes and reduced complications in patients with com.

 
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