| CTRI Number |
CTRI/2025/04/085282 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare endoscopic ear surgery with microscopic ear surgery in patients of limited chronic otitis media squamosal type. |
|
Scientific Title of Study
|
Endoscopic ear surgery versus Conventional microscopic ear
surgery in patients with limited squamosal chronic otitis media, A Randomized
Controlled 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 |
Nishtha Duggal |
| Designation |
Post graduate student |
| Affiliation |
Department of ENT AIIMS Gorakhpur |
| Address |
Department of ENT AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
|
| Fax |
|
| Email |
nduggaldoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankhuri Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Department of ENT AIIMS Gorakhpur |
| Address |
Department of ENT AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09811927490 |
| Fax |
|
| Email |
mamc.pankhuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pankhuri Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Department of ENT AIIMS Gorakhpur |
| Address |
Department of ENT AIIMS Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09811927490 |
| Fax |
|
| Email |
mamc.pankhuri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Gorakhpur |
| Address |
AIIMS Gorakhpur |
| 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 |
| Pankhuri Mittal |
AIIMS Gorakhpur |
Department of ENT, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH |
09811927490
mamc.pankhuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H710||Cholesteatoma of attic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic ear surgery |
2 groups will undergo either endoscopic ear surgery or a microscopic ear surgery and the comparison will be done using parmeters defined |
| Comparator Agent |
Microscopic ear surgery |
2 groups will undergo either endoscopic ear surgery or a microscopic ear surgery and the comparison will be done using parmeters defined |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adult patients (18-60 years)
Limited squamosal disease (not involving the antrum)
Disease extent confirmed by HRCT temporal bone
Both approaches of surgery performed by single surgeon proficient in both microscopic and endoscopic technique. |
|
| ExclusionCriteria |
| Details |
Patients with extensive disease that is involving the antrum
Patients with any otogenic complications
Revision surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of mean/median MESVI score will be considered as the primary outcome. A difference of at least 2 in
total scores between two study groups would be considered clinically significant. |
Intraoperative after completion of drilling |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean/median intraoperative duration among study group.
|
From local anaesthesia to ear packing |
Mean/median PTA-AB dB gap at 2 wk, 4 wk and 6 wk among study groups.
|
at 6 weeks post operatively |
Mean/median VAS pain score at 24 hr postoperative period among study groups.
|
24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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 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 - NO
|
|
Brief Summary
|
This RCT aims to compare endoscopic ear surgery with conventional microscopic ear surgery in patients with limited squamosal disease. The study will include 64 patients meeting inclusion criteria over 1.5 years, conducted at AIIMS Gorakhpur. The study evaluates both techniques in terms of intraoperative exposure using MESVI Score, post-operative pain, hearing improvement and healing. Findings are expected to provide evidence on weather endoscopic surgery offers advantage over microscopic for limited disease management. |