| CTRI Number |
CTRI/2022/11/047120 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/10/2022 |
| 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
|
It is a comparison between microscopic and endoscopic tympanoplasty |
|
Scientific Title of Study
|
Endoscopic versus Microscopic tympanoplasty: A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinav Srivastava |
| Designation |
Professor and HOD |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no. 1203 , ENT Department , Rohilkhand Medical College and Hospital , Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9794956306 |
| Fax |
|
| Email |
drabhinavsrivastava7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Srivastava |
| Designation |
Professor and HOD |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no. 1203 , ENT Department , Rohilkhand Medical College and Hospital , Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9794956306 |
| Fax |
|
| Email |
drabhinavsrivastava7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreevaishnavi choudhary |
| Designation |
Junior resident 1 |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road Bareilly,
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7014440448 |
| Fax |
|
| Email |
vaishchoudhary5@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Rohilkhand Medical College and Hospital ,Pilibhit Bypass Road , Suresh sharma nagar , Bareilly 243006 |
| 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 Abhinav Srivastava |
Rohilkhand medical college |
Room no. 1203 , ENT department , Rohilkhand medical college and hospital , pilibhit bypass road , opposite suresh sharma nagar , bareilly
Bareilly
UTTAR PRADESH |
9794956306
drabhinavsrivastava7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, (2) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ENDOSCOPIC APPROACH |
The tympanoplasty procedure will be done by only endoscope followed upto 3 months |
| Comparator Agent |
MICROSCOPIC APPROACH |
The tympanoplasty procedure will be done by only microscope followed upto 3 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
All patients above the age of 60 years.
Patients suffering from diabetes , hypertension, tuberculosis , any immunocompromised
disease . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graft success rate |
At 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hearing level
|
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
15/11/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic otitis media is the inflammation of mucous membrane of middle ear cleft. It presents with permanent abnormality in pars tensa or flaccida. According to WHO 65-330 million people world wide suffer from CSOM of whom 50% suffer from hearing impairement and 28000 people die per year. The hearing impairement is usually preventable if preferred intervention is taken on time . The management of chronic otitis media depends on the type of chronic otitis media . The main aim of surgery in chronic otitis media is to decrease hearing disability in the patient. Tympanoplasty is the surgery of choice amongst mucosal type of chronic otitis media. Tympanoplasty is a procedure to remove disease from middle ear and reconstruct hearing with or without tympanic membrane grafting. Conventionally Microscopic tympanoplasty is being used and still in practice for surgery for TM perforations . But since the introduction of endoscopes in the 1990s ,endoscopic tympanoplasty is emerging as an alternative for microscopic tympanoplasty . Microscopes provide the benefit of using both hands to perform surgery but with the limitation of narrow view of the surgical field and inability to access deeper areas which is possible with the use of endocopes . Though it suffers from this limitation , the use of only one hand in endoscopic surgery limits endoscope use as there is hesitancy among surgeons regarding efficacy and safety of endoscopes along with the need of special training and experience to use endoscopes . Microscopic tympanoplasty is performed through postauricular incision which increases hospital stay and discomfort of the patient whereas the use of endoscopes have reduced surgery time , hospital stay and post operative pain due to its minimally invasive procedure. The concerns regarding depth perception , steeper learning curve and chance of injury by the light source , fogging of the lens during surgery, is a limitation to endoscopic surgery. Since, there is limited literature present on this topic which compares both endoscopic and microscopic tympanoplasty. So to fill this lacunae the present study has been undertaken. |