| CTRI Number |
CTRI/2024/07/071630 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the efficacy of hearing gain and functional success between cartilage and temporal fascia grafts in patients undergoing endoscopic type 1 tympanoplasty |
|
Scientific Title of Study
|
To compare outcome between cartilage and temporal fascia grafts in endoscopic type 1 tympanoplasty.(Comparative study) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajat Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Medical College Kangra At Tanda |
| Address |
Department Of Ent, Dr Rajendra Prasad Medical College Kangra At Tanda, Distt Kangra State Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418690851 |
| Fax |
|
| Email |
rajatbhardwaj1355@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munish Saroch |
| Designation |
Professor and head |
| Affiliation |
Dr Rajendra Prasad Medical College Kangra At Tanda |
| Address |
Department Of Ent, Dr Rajendra Prasad Medical College Kangra At Tanda, Distt Kangra State Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418037099 |
| Fax |
|
| Email |
drsaroch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Medical College Kangra At Tanda |
| Address |
Department Of Ent, Dr Rajendra Prasad Medical College Kangra At Tanda, Distt Kangra State Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418690851 |
| Fax |
|
| Email |
rajatbhardwaj1355@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College Kangra At Tanda |
| Address |
Dr Rpgmc Kangra At Tanda, Distt Kangra State Himachal Pradesh Pin 176001 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajat Bhardwaj |
Dr Rajendra Prasad Medical College Tanda |
Opd 8, Department Of Ent, Dr RPGMC Tanda
Kangra
HIMACHAL PRADESH |
9418690851
rajatbhardwaj1355@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India – 176 001 Institutional Ethics Committee |
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 |
| Intervention |
cartilage graft |
use of cartilage graft in endoscopic type 1 tympanoplasty for duration of 1 year |
| Comparator Agent |
temporalis fascia graft |
use of temporalis fascia graft in endoscopic type 1 tympanoplasty for 1 year |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
2. The patients requiring type 1 tympanoplasty.
3. Central perforation.
4. Intact ossicular chain on endoscopic examination.
5. Dry ear for more than 3 months.
6. No mastoid surgery in the past.
7. Minimum follow up of 1 year.
8. Patients with informed consent.
|
|
| ExclusionCriteria |
| Details |
Affected/ distorted ossicular chain on endoscopic examination.
Total and marginal perforation.
Revision surgeries.
Cholesteatoma and retraction pockets.
Patients unwilling to participate in study.
Chronic sinusitis
allergic rhinitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The tympanic membrane being intact without retraction or lateralization at 4weeks, 12 weeks and 24 weeks, and the difference between pre op and post op air bone gap (ABG) at 24 weeks |
24 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/08/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic suppurative otitis media (CSOM) is defined as a chronic inflammation of the middle ear and mastoid cavity, which presents with recurrent ear discharges or otorrhoea through a tympanic perforation. Perforation of the tympanic membrane can result from middle ear infections, trauma or the treatment of middle ear diseases. A tympanoplasty is a surgical procedure to close a tympanic membrane perforation and reconstruct the tympanic membrane and hearing, commonly after chronic otitis media and trauma. A tympanoplasty is fundamentally a tissue transference procedure. Various graft materials have been used to close tympanic membrane perforations. These graft materials include temporalis fascia muscle, cartilage, perichondrium, dura mater, vein tissue, fat, and skin. This study aims to compare the hearing gain and structural stability of cartilage graft and temporalis fascia in patients undergoing endoscopic type 1 tympanoplasty. |