| 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
|
|
|
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
|
|
|
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. |