| CTRI Number |
CTRI/2024/05/067361 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Middle Ear Gel Foam On Outcomes After Type I Tympanoplasty |
|
Scientific Title of Study
|
“EFFECTS OF MIDDLE EAR GEL FOAM ON OUTCOMES AFTER TYPE I TYMPANOPLASTY†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikil |
| Designation |
ENT POST-GRADUATE |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Dr Nikil
G BLOCK SECOND FLOOR
SRI RAMACHANDRA HOSPITAL
1 RAMACHANDRA NAGAR
PORUR
CHENNAI
600116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9600234882 |
| Fax |
|
| Email |
s.s.nikilsthanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.L.Somu |
| Designation |
Professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA HOSPITAL
1 RAMACHANDRA NAGAR
PORUR
CHENNAI
600116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9600234882 |
| Fax |
|
| Email |
s.s.nikilsthanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikil |
| Designation |
ENT POST-GRADUATE |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Dr Nikil
G BLOCK SECOND FLOOR
SRI RAMACHANDRA HOSPITAL
1 RAMACHANDRA NAGAR
PORUR
CHENNAI
600116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9600234882 |
| Fax |
|
| Email |
s.s.nikilsthanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA HOSPITAL AND RESEARCH INSTITUTE,
Chennai - 600116
Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
G BLOCK SECOND FLOOR
SRI RAMACHANDRA HOSPITAL
1 RAMACHANDRA NAGAR
PORUR CHENNAI
PORUR CHENNAI |
| 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 NIKIL |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
OTORHINOLARYNGOLOGY DEPARTMENT
Room number 21
Chennai
TAMIL NADU |
9600234882
s.s.nikilsthknu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H652||Chronic serous otitis media, (2) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (3) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Type I tympanoplasty without gel foam packing
|
INTERVENTION: Type I Tympanoplasty
- repair of tympanic membrane without gel foam packing
Duration of study : 6 months
To assess the graft uptake and hearing following type 1 tympanoplasty without gelfoam packing and monitored post operatively
|
| Intervention |
Type I tympanoplasty , with gel foam packing
|
INTERVENTION: Type I Tympanoplasty - repair of tympanic membrane with gel foam packing
Duration of study - 6 months.
CASE GROUP - To assess the graft uptake and hearing following type 1 tympanoplasty with gel foam packing post operatively.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with central perforation in tympanic membrane who require Type I Tympanoplasty |
|
| ExclusionCriteria |
| Details |
Patient below 18 or above 70 years of age
Patients who requires ossiculoplasty.
Patients currently having ear discharge.
Patients with history of previous surgery to ear
Unsafe Ear pathology, SNHL/mixed hearing loss.
Patient with cleft palate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the graft uptake and hearing following type 1 tympanoplasty with and without gelfoam packing in the middle ear. |
12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the complications in both techniques |
MONITORING TWICE IN 12 WEEKS TIME POINT |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 4 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| 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="0"
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
|
This prospective randomized case-control study was performed to compare the surgical outcomes of tympanoplasty with or without gel foam packing in the middle ear in patients with chronic otitis media (COM), according to the surgical procedure. Following preoperative evaluation, the patients are taken up for Type 1 tympanoplasty by postaural approach. Packing of the middle ear is performed based on the group to which the patient belongs. · Group A: packing of middle ear done with Gel foam. · Group B: middle ear not packed.with gel foam The patient’s ear is then monitored at regular intervals for signs of graft failure and infections. Assesment with Pure tone audiometry and Impedence is performed at 12 weeks post surgery. .These datas will be compiled and will be used for publications. |