| CTRI Number |
CTRI/2017/07/009165 [Registered on: 28/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison betwee surgeries using endoscope and microscope for treating unsafe type of middle ear infection |
|
Scientific Title of Study
|
Comparison of Endoscope assisted and Microscope assisted Ear Surgery in Chronic Otitis Media(Squamous Type)-A Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri Bhaskaran |
| Designation |
Junior Resident |
| Affiliation |
Autonomous |
| Address |
Department of Otorhinolaryngology, Jawaharlal Nehru Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9176841240 |
| Fax |
|
| Email |
gayathri.kongot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sunil Kumar Saxena |
| Designation |
Senior Professor |
| Affiliation |
Autonomous |
| Address |
Department of Otorhinolaryngology,
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442527018 |
| Fax |
|
| Email |
saxenasunil.jipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhaskaran |
| Designation |
Junior Resident |
| Affiliation |
Autonomous |
| Address |
Department of Otorhinolaryngology,
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9176841240 |
| Fax |
|
| Email |
gayathri.kongot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Institiute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Institiute of Postgraduate Medical Education and Research |
| Address |
Dhanvantri Nagar, Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gayathri Bhaskaran |
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research |
Deparment of Otorhinolaryngology,
JIPMER
Dhanvantri Nagar , Puducherry 605006
Pondicherry
PONDICHERRY |
9176841240
gayathri.kongot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee(Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS HAVING CHRONIC OTITIS MEDIA (SQUAMOUS TYPE) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscope assisted Ear surgery |
using zero degree endoscope , disease clearance done in patients with chronic otitis media (Squamous type) |
| Comparator Agent |
Microscope assisted ear surgery |
using Operating microscope, disease clearance done in patients with chronic otitis media (Squamous type) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age limits who attend ENT OPD and diagnosed with Chronic Otitis Media(Squamous type) with no previous surgical intervention are recruited. |
|
| ExclusionCriteria |
| Details |
1.Patients with Otitis externa
2.Patients with other comorbidities like Diabetes and Hypertension,
3.Patient with intracranial complications of CSOM, Patients with dead ear and patients with ear malformations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Disease clearance
2.Hearing improvement |
6 months after the each patient is operated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
03/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objectives of the study are to assess and compare the
efficacy of endoscopic ear surgery with microscope assisted surgical
techniques on disease clearance and to compare the postoperative hearing improvement after these techniques among the patients with chronic otitis
media- squamous type.The study hypothesis is ’Endoscope is better than
microscope assisted ear surgery in terms of disease clearance and hearing
improvement in patients diagnosed with chronic
suppurative otitis media (squamous type)’ .
|