| CTRI Number |
CTRI/2026/01/102000 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [prospective comparative] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Role of Cortical Mastoidectomy in Improving Tympanoplasty Outcomes in Mucosal Chronic Otitis Media |
|
Scientific Title of Study
|
Efficacy of Cortical Mastoidectomy in optimising post tympanoplasty outcomes: A comparative study on hearing restoration and graft success in chronic otitis media mucosal type |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeslin Mole Jose |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8943529103 |
| Fax |
|
| Email |
jeslinmoljose.j@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivakumar S |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9345761230 |
| Fax |
|
| Email |
drshiva73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivakumar S |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
Vinayaka Missions Kirupananda Variyar Medical College and Hospital
Chinnaseeragapadi, Salem
TAMIL NADU
636308
India |
| Phone |
9345761230 |
| Fax |
|
| Email |
drshiva73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Jeslin Mole Jose |
| Address |
Department of ENT, Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Salem
TAMIL NADU
636308
India |
| 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 |
| Jeslin Mole Jose |
Vinayaka Missions kirupananda variyar Medical College |
Department of Otorhinolaryngology, Chinnasreeragapadi, Salem 636308
Salem
TAMIL NADU |
8943529103
jeslinmoljose.j@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Cortical Mastoidectomy with tympanoplasty and Tympanoplasty |
Patients with CSOM Mucosal type are treated with surgical management cortical mastoidectomy with tympanoplasty and tympanoplasty |
| Comparator Agent |
Cortical Mastoidectomy with tympanoplasty compare with Tympanoplasty |
Patients were allocated to two surgical groups.
Group A underwent tympanoplasty alone, which involved elevation of the tympanomeatal flap, assessment of the middle ear and ossicular chain, excision of the retraction pocket if present, and reconstruction of the tympanic membrane using temporalis fascia or cartilage graft.
Group B underwent cortical mastoidectomy with tympanoplasty, which included a postauricular approach, cortical mastoidectomy with clearance of mastoid air cells and aditus ad antrum, followed by tympanoplasty performed in a similar manner to Group A. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 15 to 60 years
Diagnosed with CSOM (tubotympanic type)
Dry ear for at least 2 weeks before surgery
Complying to regular follow up
Willing to provide informed consent and follow up
|
|
| ExclusionCriteria |
| Details |
Presence of cholesteatoma or atticoantral disease
Revision tympanoplasty cases
No previous mastoid surgery
Patients not consenting for the study
Patients with sensorineural hearing loss or mixed hearing loss
Immunocompromised patients or those with uncontrolled comorbidities
Unfit for general anesthesia
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Graft Uptake Rate:
Defined as successful closure of the tympanic membrane perforation at 3 months postoperatively, confirmed via otoscopic or microscopic examination.
|
Graft Uptake Rate:
Defined as successful closure of the tympanic membrane perforation at 3 months postoperatively, confirmed via otoscopic or microscopic examination.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hearing Improvement:
Measured using Pure Tone Audiometry.
Air-Bone Gap was calculated at frequencies of 500 Hz, 1000 Hz, and 2000 Hz.
Preoperative and postoperative at 6–12 weeks ABG values were compared.
Significant hearing improvement was defined as a less than or equal to 10 dB reduction in ABG
|
During the post operative follow up for Hearing Improvement and graft uptake |
|
|
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)
|
10/02/2026 |
| 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="6"
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 prevalent condition characterized by persistent inflammation of the middle ear and mastoid cavity, often resulting in tympanic membrane perforation and conductive hearing loss. Tympanoplasty, a surgical procedure aimed at reconstructing the tympanic membrane and restoring hearing, remains a cornerstone in the management of CSOM. In some cases, cortical mastoidectomy is performed in conjunction with tympanoplasty to eradicate infection and ensure a dry ear This study aims to compare the anatomical and functional outcomes of tympanoplasty performed with and without cortical mastoidectomy. Specifically, it will evaluate graft uptake success and hearing improvement postoperatively |