| CTRI Number |
CTRI/2024/11/076192 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of balloon eustachian tuboplasty in patients with eustachian tube dysfunction |
|
Scientific Title of Study
|
Efficacy of Balloon Eustachian Tuboplasty in cases of unresolved otitis media with effusion and pars tensa retractions
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ardhendu Sekhar Kar |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of ENT and head and neck surgery, room no 612, opd block, lok nayak hospital, Maulana Azad medical college and associated hospitals
LNJP Colony New DELHI 110002
Central
DELHI
110002
India |
| Phone |
8826365444 |
| Fax |
|
| Email |
ardhenduask@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Rathore |
| Designation |
Professor of excellence |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja block, lok nayak hospital, Maulana Azad medical college and associated hospitals
LNJP Colony New DELHI 110002
Central
DELHI
110002
India |
| Phone |
9868100337 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar Rathore |
| Designation |
Professor of excellence |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja block, lok nayak hospital, Maulana Azad medical college and associated hospitals
LNJP Colony New DELHI 110002
DELHI
110002
India |
| Phone |
9868100337 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college Bahadur shah zafar Marg New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical college Bahadur Shah Zafar Marg New Delhi
110002 |
| 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 Ardhendu Sekhar Kar |
Lok Nayak Hospital |
Department of ENT and head and neck surgery, room no 612, opd block, lok nayak hospital, Maulana Azad medical college and associated hospitals
LNJP Colony New DELHI 110002
Central
DELHI |
8826365444
ardhenduask@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college and associated hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H681||Obstruction of Eustachian tube, (2) ICD-10 Condition: H681||Obstruction of Eustachian tube, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18 to 60 years with Grade 2 or 3 pars tensa retractions or secretory otitis media not responding to medical management. |
|
| ExclusionCriteria |
| Details |
1. Any previous surgical intervention done on tympanic membrane and Eustachian tube
2. Pars tensa retractions type 4 (Sadé classification)
3. Carotid artery dehiscence
4. Active upper respiratory tract infection and middle ear infections
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical efficacy of Balloon Eustachian Tuboplasty in treating refractory otitis media with effusion and pars tensa retractions by Eustachian Tube Dysfunction Quality (ETDQ) Score |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical efficacy of Balloon Eustachian Tuboplasty in treating refractory otitis media with effusion and pars tensa retractions by
1. Comparing pre and post operative impedance audiometry findings
2. Comparing pre and post operative pure tone audiometry findings
|
2 Months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
15/11/2024 |
| 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="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
|
The study will be conducted after getting approval from the protocol review committee and ethics committee. The study will be registered in clinical trial registry India (CTRI). Informed consent/ assent will be taken from all the patients. Patients meeting inclusion criteria will be taken up for Balloon eustachian tuboplasty.
PREOPERATIVE ASSESSMENT After noting personal data such as age and sex of patient, a detailed history will be noted. Family history and any past treatment history will also be noted. Routine blood investigations, pure tone audiometry and impedence audiometry will be done for all patients preoperatively. The patient will also be given a Eustachian tube dysfunction score test.
Anesthesia fitness and clearance
INTRAOPERATIVE TECHNIQUE All surgeries will be performed by the same surgeon, under general anesthesia. The procedure will begin with nasal mucosa decongestion with nasal swabs soaked in adrenaline at a dilution of 1:10000. Balloon Eustachian Tuboplasty will be
performed with a Balloon Eustachian Tube dilator. The instrument will be
introduced trans nasally into the nasopharyngeal orifice of the ET and the
cartilaginous part of the ET. The introduction will be visualized with a trans
nasally inserted, rigid endoscope (bent at 30 degree, 4-mm diameter) with high
resolution. The balloon will be filled with saline to
a target pressure of 10 bar with an insufflation pump. This pressure will be
applied for 2 minutes. Then, the saline will be drained. This procedure will be
repeated 2 times more and then balloon will be pulled out of the nasal cavity,
together with the inserter.
POSTOPERATIVE ASSESSMENT The patient will be started on topical steroid sprays and valsalva maneuver. The patient will be assessed at 2 months postop using Eustachian tube dysfunction score, Pure tone audiometry and Impedence audiometry which will be compared to preoperative values to check the efficacy of the procedure. TH |