| CTRI Number |
CTRI/2025/07/091865 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing ear surgery results in patients with and without eustachian tube opening treatment, using a sweet-tasting test to check tube function: A randomised trial |
|
Scientific Title of Study
|
Comparative Outcomes of Tympanoplasty in Patients with Eustachian Tube Dilation vs. Without Eustachian Tube Dilation Using Saccharine test for Diagnosing Eustachian Tube Dysfunction: A Randomised Control Trial |
| 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 Vasista Padhi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 2227, Department of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Room No 2227, Department of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
7989643586 |
| Fax |
|
| Email |
vasista10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Saini |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 2228, Department Of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Room No 2228, Department Of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
8872377681 |
| Fax |
|
| Email |
drvaibhavsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Saini |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 2228, Department Of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Room No 2228, Department Of ENT, 2nd Floor B Block, All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
8872377681 |
| Fax |
|
| Email |
drvaibhavsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, mandi dabwali road, bathinda, Punjab, India. Pincode 151001 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Bathinda |
| Address |
All India Institute Of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab, India 151001 |
| 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 |
| DR VAIBHAV SAINI |
All India institute of medical sciences bathinda |
Ent department, 2nd floor, B block, room 2227, AIIMS, mandi dabwali road, bathinda, Punjab.
Bathinda
PUNJAB |
8872377681
drvaibhavsaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BATHINDA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eustachian tube dilation in patients undergoing tympanoplasty with eustachian tube dysfunction |
eustachian tube is dilated using eustachian balloon catheter at 10 atm pressure for 2 minutes before performing tympanoplasty. |
| Comparator Agent |
Tympanoplasty without eustachian tube dilation in patients with eustachian tube dysfunction |
Tympanoplasty is performed without eustachian tube dilation in patients with eustachian tube dysfunction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 50 years with a perforation of the tympanic membrane.
Patients with eustachian tube dysfunction identified using saccharine test. |
|
| ExclusionCriteria |
| Details |
Patient refusal of consent
Patients with chronic middle ear disease, cholesteatoma.
Previous ear surgeries (except for minor procedures).
eustachian tube defects due to anatomical abnormalities
Patients with normal saccharine test time
Patients with immunocompromised conditions- diabetic, hypertensive, HIV, autoimmune
diseases.
Patients with nasal pathologies ( polyps, afrs) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine graft uptake rates among patients with eustachian tube dysfunction who undergo
eustachian tube dilatation and those who do not. |
To determine graft uptake rates with no residual perforation at 1 week, 1 month , 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess improvement in air bone gap closure in both groups.
To assess complications postoperatively(e.g., recurrence of perforation, hearing loss) in both
groups. |
improvement in air bone gap by performing pure tone audiometry at 1month, 3 month, 6 month.
To assess complications postoperatively at day 1, 1week, 1 month, 3 month, 6 month.
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
11/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - BY CONTACTING ALL INDIA INSTITUTE OF MEDICAL SCIENCES BATHINDA PUNJAB
- For how long will this data be available start date provided 01-09-2027 and end date provided 01-09-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Tympanoplasty is a surgical procedure done for repairing of perforated tympanic membrane i.e eardrum along with repair of middle ear structures, eustachian tube dysfunction is a common condition which affects the capacity of middle ear to regulate air pressure and drain fluids collected in middle ear which leads to persistent ear problems and compromising the outcome of ear surgeries including tympanoplasty , the Eustachian tube plays a major role in regulating the pressure within the middle ear., failure to mark eustachian tube dysfunction may cause recurrent ear infections, middle ear effusions, and unfavourable outcomes post tympanoplasty. Recent innovations like eustachian tube dilation aims to address the dysfunction by improving its function which can be done preoperatively or intraoperatively. In this study we explore the effectiveness of intraoperative eustachian tube dilation using saccharine as guide to assess eustachian tube dysfunction preoperatively. The saccharine test involves instillation of saccharine pellet through perforated tympanic membrane and monitoring its detection in the throat after passage through eustachian tube. Objective is to find out whether intraoperative eustachian tube dilation improves surgical outcome for tympanoplasty compared to those who do not undergo eustachian tube dilation? The hypothesis is that eustachian tube dilation using balloon technique and using saccharine as guide will result in significant better surgical outcomes for tympanoplasty, with better graft uptake and better hearing improvement compared to patients who do not undergo dilation.Tympanoplasty is a surgical procedure done for repairing of perforated tympanic membrane i.e eardrum along with repair of middle ear structures, eustachian tube dysfunction is a common condition which affects the capacity of middle ear to regulate air pressure and drain fluids collected in middle ear which leads to persistent ear problems and compromising the outcome of ear surgeries including tympanoplasty , the Eustachian tube plays a major role in regulating the pressure within the middle ear., failure to mark eustachian tube dysfunction may cause recurrent ear infections, middle ear effusions, and unfavourable outcomes post tympanoplasty. Recent innovations like eustachian tube dilation aims to address the dysfunction by improving its function which can be done preoperatively or intraoperatively. In this study we explore the effectiveness of intraoperative eustachian tube dilation using saccharine as guide to assess eustachian tube dysfunction preoperatively. The saccharine test involves instillation of saccharine pellet through perforated tympanic membrane and monitoring its detection in the throat after passage through eustachian tube. Objective is to find out whether intraoperative eustachian tube dilation improves surgical outcome for tympanoplasty compared to those who do not undergo eustachian tube dilation? The hypothesis is that eustachian tube dilation using balloon technique and using saccharine as guide will result in significant better surgical outcomes for tympanoplasty, with better graft uptake and better hearing improvement compared to patients who do not undergo dilation. |