| CTRI Number |
CTRI/2024/03/064655 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Endoscopic transcanal tympanoplasty and conventional post aural aproach tympanoplasty- A comparative study |
|
Scientific Title of Study
|
Comparative study of endoscopic transcanal tympanoplasty with tympanoplasty by conventional post aural aproach |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasleen kaur |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College
Datta Meghe Institute of Higher Education and Research, Sawangi meghe,wardha,
Wardha
MAHARASHTRA
442001
India |
| Phone |
8889851000 |
| Fax |
0 |
| Email |
jasleenkakkad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P T Deshmukh |
| Designation |
professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and Research. Sawangi meghe,wardha,
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765404133 |
| Fax |
0 |
| Email |
drprasaddeshmukh1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasleen kaur |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research
Sawangi meghe,wardha,
Wardha
MAHARASHTRA
442001
India |
| Phone |
8889851000 |
| Fax |
0 |
| Email |
jasleenkakkad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi Meghe , Wardha |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL NEHRU MEDICAL COLLEGE SAWANGI MEGHE WARDHA |
| Address |
Jawaharlal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi Meghe , Wardha , 442001 |
| Type of Sponsor |
Private 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 Jasleen Kaur |
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research |
Department of Otorhinolaryngology, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research, SAWANGI MEGHE 442001
Wardha
MAHARASHTRA |
8889851000
0
jasleenkakkad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences [Deemed to be university Institutional Ethics Committiee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
APPROACHES OF TYMPANOPLASTY |
Comparative study of endoscopic transcanal tympanoplasty with tympanoplasty by conventional post aural aproach, with use of PRP. Study will be conducted at Department of E.N.T, AVBRH Sawangi wardha. during a period of June 2022 to june 2025.A sample size of 60 patients, with COM satisfying the -inclusion criteria will be considered and included in this study. Patients will be comprehensively examined as per the proforma enclosed and baseline investigations will be done. Those patients from casualty, OPD, ward, included in this study. |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) central perfortaion – small/ moderate/ large
2) dry middle ear cavity
3) no active diseases of nose and throat
4) functioning eustachian tube
|
|
| ExclusionCriteria |
| Details |
1. chronic otitis media of squamosal type
2. ossicular involvement
3. symptomatic dns
4. chronic liver diseases
5. chronic kidney disease
6. uncontrolled diabeties
7. uncontrolled hypertension
8. hypofibrogenemia
9. low platelet count
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is to compare functional and anatomical outcomes in endoscopic transcanal tympanoplasty and tympanoplasty by conventional post aural approach |
in 3 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The purpose of this study is to compare functional & anatomical outcomes in endoscopic transcanal tympanoplasty & tympanoplasty by conventional post aural approach with & without use of platelet rich plasma in either of the groups.
to compare quality of life in patient who underwent endoscopic tympanoplasty & tympanoplasty by conventional postauricular approach
- functional outcome will be compared by pure tone audiometry
- anatomical outcome will be compared by otoscopy
- quality of life will be compared by questionare to the patient |
3 years |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="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 help the clinicians for better understanding of the different approaches of tympanoplasty and benefits of use of PRP in ear surgery, which will guide towards better patient care. The use of PRP in tympanoplasty involves the application of a concentrated solution of platelets and growth factors to the surgical site, which is believed to enhance tissue regeneration and improve healing The study includes detailed information on the surgical techniques and postoperative care, allowing for standardized procedures and minimizing variations in the surgical outcomes. The use of statistical analysis to compare the results between the two groups further ensures the reliability and validity of the study. Overall, this comparative study provides a rigorous and systematic approach for evaluating the safety and efficacy of endoscopic transcanal tympanoplasty with tympanoplasty by conventional postaural approach. The results of this study have the potential to inform clinical practice and improve patient outcomes in the management of chronic otitis media. |