| CTRI Number |
CTRI/2022/04/041917 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| 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
|
A clinical trial to compare the outcomes of 2 types of tympanoplasty in terms of improvement in hearing and non discharging ear, the conventional tympanoplasty and total annular excision tympanoplasty |
|
Scientific Title of Study
|
A randomized control study to compare the outcomes of total annular excision tympanoplasty and conventional tympanoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anwer shah PA |
| Designation |
Juniour resident, Department of ENT and Head and Neck Surgery |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of ENT and head and Neck Surgery, AIIMS Bhubaneswar
SIJUA, PATRAPADA
Khordha
ORISSA
751019
India |
| Phone |
9497443883 |
| Fax |
|
| Email |
anwershah4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Saurav Sarkar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Medical Education Unit
second floor, Academic block
SIJUA, PATRAPADA
Khordha
ORISSA
751019
India |
| Phone |
9497443883 |
| Fax |
|
| Email |
doc.sauravsarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anwer Shah P A |
| Designation |
Juniour resident, Department of ENT and Head and Neck Surgery |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of ENT and head and Neck Surgery, AIIMS Bhubaneswar
SIJUA, PATRAPADA
Khordha
ORISSA
751019
India |
| Phone |
9497443883 |
| Fax |
|
| Email |
anwershah4u@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada |
| 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 |
| ANWER SHAH P A |
AIIMS Bhubaneswar |
ENT H5 ward, AIIMS Bhubaneswar, Sijua, Patrapada, Khorda, odisha , India
Khordha
ORISSA |
9497443883
anwershah4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
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 |
| Comparator Agent |
conventional tympanoplasty |
tympanomeatal flap will be elevated and graft will be placed medial to the handle of malleus. PTA and otoscopy findings shall be documented at 3 months postop |
| Intervention |
total annular excision tympanoplasty |
the remaining annulus of the tympanic membrane shall be removed and graft placed over the bony annulus. PTA and otoscopy shall be done after 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic otitis media of the mucosal type with large, subtotal and total perforations.
Air bone gap in pure tone audiometry > 20 dB
|
|
| ExclusionCriteria |
| Details |
1.Patients having active discharge at presentation
2.Patients having history of previous surgeries on the same side of planned operation
3.Patients having small central perforations
4.Age less than 18 years and more than 60 years
5.Patients having sensorineural component in Pure tone audiogram.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Graft uptake will be measured by otoscopy
2.Hearing gain will be measured by pure tone audiometry.
3.Quality of life assessment scores using questionnaire prepared by the investigator
( based on chronic ear survey by Massachusetts Eye and Ear)
|
2 weeks, 1 month and 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
quality of life assessment scores using questionnaire prepared by the investigator
( based on chronic ear survey by Massachusetts Eye and Ear)
|
2 week, 1 month, 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the complication associated with the
conventional technique of tympanoplasty is a continuously discharging tympanic membrane- an entity named red drum
conundrum. Mucosalisation of the graft Post tympanoplasty, may lead to
continuous or intermittent discharging ear despite an intact tympanic membrane.
The
postoperative ear drum is seen to be red, glistening , discharging and intact,
which causes endless trouble to the patient. This would sometimes also require
a revision surgery with excision of the mucous membrane.
In the underlay technique, the surgeon often would have
to lay a large volume of remnant tympanic membrane lateral to the graft. Proliferation
and survival of tympanic membrane that is left laterally to graft creates
island of discharging mucous membrane. Another postulate for the discharging
tympanic membrane being that; mucous membrane grows at faster rate during
postoperative healing than the epithelium, so that tympanic membrane has mucosa
over the lateral surface.
The novel method aims to correct deficiencies of the
underlay technique, by excising the complete annulus of the remaining
perforated tympanic membrane. The study aims to compare the graft uptake and
improvement of hearing in patients undergoing conventional tympanoplasty and
those undergoing total annulus excision.
|