| CTRI Number |
CTRI/2025/11/096830 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| 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 comparing the benefits of using Single and Double Layer Fascia Grafts in Tympanic Membrane Perforation Repair Surgery |
|
Scientific Title of Study
|
A Study Comparing the outcomes of Double Layer Vs Single Layer Temporalis Fascia Graft in Type 1 Tympanoplasty for Subtotal and Anterior Perforations |
| 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 ASMIT BANSAL |
| 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 |
7340589697 |
| Fax |
|
| Email |
asmitbansal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhana Krishnan Kaliavardan |
| Designation |
HOD and Professor ENT |
| 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 |
8940132448 |
| Fax |
|
| Email |
santhanakrishnan2709@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 ,Banthra,Shahjahanpur, Uttar Pradesh, India(242307) |
|
|
Primary Sponsor
|
| Name |
Dr Asmit Bansal |
| 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 Asmit Bansal |
Varun Arjun Medical College and Rohilkhand Hospital |
Room No. 248, Otorhinolaryngology Department,Banthra,Shahjahanpur,Uttar Pradesh(242307)
Shahjahanpur
UTTAR PRADESH |
7340589697
Asmitbansal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,VAMC, Banthra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, (2) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double Layer Temporalis Fascia Graft |
Patient undergoing Type 1 Tympanoplasty with Double Layer Temporalis Fascia Graft in Subtotal and Anterior Perforations which will be done for 1 year |
| Comparator Agent |
Single Layer Temporalis Fascia Graft |
Patient undergoing Type 1 Tympanoplasty with Single Layer Temporalis Fascia Graft in Subtotal and Anterior Perforations which will be done for 1 year |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with inactive chronic otitis media (tubotympanic disease) ;Patient willing to participate in study,Patient with conductive Hearing Loss with AB Gap of less than 45dB;Subtotal/Anterior perforation in TM |
|
| ExclusionCriteria |
| Details |
Patient with recurrent chronic otitis media;Patient with central perforation with active discharge;Patient with Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension and Bronchial Asthma and Tuberculosis ,Patient with mixed hearing loss |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of graft uptake between Double Layer versus Single Layer Temporalis Fascia Graft |
Once weekly for one month
Fortnightly for three months
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the hearing outcome in Double Layer vs Single Layer Temporalis Graft |
6th week
3rd Month
6th Month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
20/11/2025 |
| 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 Applicable |
| 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 Double Layer vs Single Layer Temporalis Fascia Graft in Type 1Tympanoplasty for Subtotal and Anterior Perforations “ will be conducted in department of Otorhinolaryngology,Varun Arjun Medical college and Rohilkhand Hospital,Banthra,Shahjahanpur,Uttar Pradesh 242307 A. The study will be conducted on subjects having tympanic membrane perforation attending the outpatient clinic in department of otorhinolaryngology , Varun Arjun Medical College and Rohilkhand Hospital ,Banthra ,Shahjahanpur,Uttar Pradesh based on inclusion and exclusion criteria B. All patients selected for the study will undergo detailed history taking and written informed consent C. Otorhinolaryngology assessment D. Laboratory assessment E. Patient will be admitted one day before the surgery F. Patient will be allocated randomly into 2 groups: Group A -Patient undergo Type 1 Tympanoplasty with Double Layer Temporalis Fascia Graft Group B- Patient undergo Type 1 Tympanoplasty with Single Layer Temporalis Fascia Graft |