| CTRI Number |
CTRI/2025/02/080679 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the hearing result of various techniques of ossicle repair for chronic middle ear infection. |
|
Scientific Title of Study
|
A study on audiological outcome of various ossiculoplasty techniques in the surgical management of chronic otitis media. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monjita Borthakur |
| Designation |
Post graduate trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology Silchar Medical College and Hospital, Ghungoor, Dist Cachar
Cachar
ASSAM
788014
India |
| Phone |
8486879863 |
| Fax |
|
| Email |
monjitaborthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology Silchar Medical College and Hospital, Ghungoor, Dist Cachar
Cachar
ASSAM
788014
India |
| Phone |
9435072159 |
| Fax |
|
| Email |
dr.abhinandan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Otorhinolaryngology Silchar Medical College and Hospital, Ghungoor, Dist Cachar
Cachar
ASSAM
788014
India |
| Phone |
9435072159 |
| Fax |
|
| Email |
dr.abhinandan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital, Ghungoor, Cachar, Assam 788014 |
|
|
Primary Sponsor
|
| Name |
Dr Monjita Borthakur |
| Address |
Department of Otorhinolaryngology Silchar Medical College and Hospital, Ghungoor, Dist Cachar |
| 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 Monjita Borthakur |
Silchar Medical College and Hospital |
Department of Otorhinolaryngology, second floor
Cachar
ASSAM |
8486879863
monjitaborthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Silchar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OSSICULOPLASTY |
Ossiculoplasty is reconstruction of
the ossicular chain which aims to surgically optimize the middle ear transformer mechanism so that
sound energy is conducted from the environment to the inner ear fluid with only minimal losS |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with chronic otitis media with indications of ossicular reconstruction.
2. Patients with ossicular discontinuity presenting with conductive hearing loss. |
|
| ExclusionCriteria |
| Details |
Patients presenting with acute suppurative otitis media, otosclerosis, congenital hearing
disorder, sensorineural and mixed hearing loss.
Patients with systemic disease and other complications making unfit for surgery.
Ear malignancy.
Revision surgery.
Patients with congenital ear disease.
Cases with intact ossicles. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the audiological outcome among different types of ossciculoplasty procedures done
in such patients. |
3 weeks, 6 weeks and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inspection of the mastoid cavity to determine whether discharge was still present or not & the status of the neo tympanic membrane. |
6 weeks & 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/02/2025 |
| 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
|
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 a major health care problem mostly presents with
discharging ear. In 400 B.C. in Sushruta Samhita it was mentioned as Putikarna (pus in ear)6.
According to WHO 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. Prevalence surveys show that the global burden of illness from
CSOM involves 65–330 million individuals with draining ears, 60% of whom (39–200 million) suffer
from significant hearing impairment.5 This persistent disease is capable of irreversible destruction of
middle ear structures and grave complications. The 1993 World Development Report (185) estimated
that about 5.12 million disability-adjusted life-years (DALYs) were lost from otitis media, 91% of
which comes from the developing world.5
Ossicular chain damage from chronic ear disease is a significant problem in the practice of
otorhinolaryngology leading to conductive hearing loss. One of the most intriguing topics in middle
ear surgery is the reconstruction of this conductive mechanism. Ossiculoplasty is reconstruction of
the ossicular chain which aims to surgically optimize the middle ear transformer mechanism so that
sound energy is conducted from the environment to the inner ear fluid with only minimal loss.1. Ever
since Matte’s first myringostapediopexy in 1901, there has been a quest for the ideal middle ear
implant with the understanding that the middle ear environment in chronic ear disease is probably the
main factor in determining treatment success.2 3 Hall and Rytzner (1957) performed the first ossicular
reconstruction using autologous incus which has been the most common autograft material and is
often reshaped to fit between the manubrium of the malleus and the stapes head4.
The Austin classification of ossicular problems is very practical. Due to the wide variability
of techniques and implants available today, reconstructions are generally reported without reference
to a particular classification and instead include a detailed description of the type of prosthesis used,
how it is interposed between the ossicular defect, and the use of other interposed or stabilizing grafting
materials1. Ossicular reconstruction is performed in otherwise healthy ears or in conjunction with a
tympanoplasty and mastoidectomy for chronic ear disease. Long term success of ossicular
reconstruction depends upon five factors- 1. surgery (open versus closed mastoidectomy), 2.
prosthesis type, 3. presence of infection, 4. tissue health., and 5. Eustachian tube function. These five
factors allow for an accurate preoperative individual assessment when counselling patients regarding
the likelihood of success of a proposed ossicular reconstruction7.
The purpose of undertaking this study is to evaluate the surgical as well as audiological
outcome of various techniques of ossicular chain reconstruction which acts by re-establishment of
middle ear mechanics using autologous grafts (autologous incus, malleus, cartilage) carried out in the
management of chronic otitis media. |