| CTRI Number |
CTRI/2026/02/103529 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two patient group with two different types of graft that will be used for Type 1 tympanoplasty - a type of Tympanic membrane perforation repair |
|
Scientific Title of Study
|
Comparison of Temporalis Fascia Graft versus Tragal Composite Graft in Type 1 Tympanoplasty: A Randomized 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 |
Prof Dr Sudhiranjan Thingbaijam |
| Designation |
Professor and Head of Department |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Room no 206, Department of OTORHINOLARYNGOLOGY, RIMS IMPHAL
Lamphelpat, Imphal
Imphal West
MANIPUR
795001
India |
| Phone |
9862189195 |
| Fax |
|
| Email |
sudhirthdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sudhiranjan Thingbaijam |
| Designation |
Professor and Head of Department |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Room no -206, Department of OTORHINOLARYNGOLOGY,RIMS IMPHAL
Lamphelpat, Imphal
Imphal West
MANIPUR
795001
India |
| Phone |
9862189195 |
| Fax |
|
| Email |
sudhirthdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sudhiranjan Thingbaijam |
| Designation |
Professor and Head of Department |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Room no -206, Department of OTORHINOLARYNGOLOGY,RIMS IMPHAL
Lamphelpat, Imphal
Imphal West
MANIPUR
795001
India |
| Phone |
9862189195 |
| Fax |
|
| Email |
sudhirthdr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Attadeep Bose |
| Address |
ENT DEPARTMENT, REGIONAL INSTITUTE OF MEDICAL SCIENCES,IMPHAL
Country - India
pin-795001 |
| 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 Attadeep Bose |
Regional institute of Medical Sciences |
Department of OTORHINOLARYNGOLOGY, RIMS Imphal
Imphal West
MANIPUR |
7085664230
rimobose607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Type 1 Tympanoplasty with Temporalis Fascia Graft |
Type 1 Tympanoplasty involves repair of tympanic membrane alone when the middle ear mucosa is normal with intact ossicular chain.A type 1 tympanoplasty is synonymous with myringoplasty.
Temporalis fascia Graft - A Temporalis fascia graft is a piece of tissue taken from fascia layer covering temporalis muscle.
The study will be conducted for a duration of 1 year |
| Intervention |
Type 1 tympanoplasty with Tragal composite Graft |
Type 1 Tympanoplasty involves repair of tympanic membrane alone when the middle ear mucosa is normal with intact ossicular chain.A type 1 tympanoplasty is synonymous with myringoplasty.
Tragal Composite graft- A Tragal composite graft refers to piece of cartilage harvested from tragus which is fleshy prominent in front of ear canal
The study will be conducted for a duration of 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years and above 2.Central perforation of tympanic membrane irrespective of cause of perforation 3. A dry ear for at least 6 weeks. |
|
| ExclusionCriteria |
| Details |
1.patient with near total or total perforation 2.Revision Tympanoplasty 3.Patient with chronic otitis media squamousal type with cholesteatoma or retraction pockets 4.Sensorineural hearing loss. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Graft uptake Rate at 3rd post operative month , 6th post operative month and at 1 year. 2. Post operative hearing outcome in terms of air bone gap at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz at 3rd post operative month, 6th post operative month and at 1 year . |
1.Graft uptake Rate at 3rd post operative month , 6th post operative month and at 1 year. 2. Post operative hearing outcome in terms of air bone gap at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz at 3rd post operative month, 6th post operative month and at 1 year . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
20/02/2026 |
| 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="2"
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
|
This study will be conducted in Tertiary Health Care centre in Manipur for a period of 2 years. The study will include patient with age 18 years and above attending in OPD of Otorhinolaryngology in RIMS, IMPHAL with diagnosis of Tympanic Membrane perforation and planned for Type 1 tympanoplasty full-filling the inclusion criteria. A total of 108 patients will be selected for the study. Block Randomization will be used and randomization sequence will be generated using www.sealedenvelope.com by entering the required data.codes will be assigned to each patient. The study will aim to compare post operative outcomes in Temporalis Fascia Graft vs Tragal Composite Graft in Type 1 Tympanoplasty in terms of Graft Uptake Rate and Hearing Outcome . |