| CTRI Number |
CTRI/2019/08/020825 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
19/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Prospective observational study |
| Study Design |
Other |
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Public Title of Study
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Use of temporal bone CT scan in patients with ear infection |
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Scientific Title of Study
|
Role of high resolution computed tomography temporal bone in evaluation of patients with chronic suppurative otitis media |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Kumar Singhal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
8256924087 |
| Fax |
|
| Email |
rahul.dmv@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lakshmikanth H K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9740730283 |
| Fax |
|
| Email |
hkkanha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lakshmikanth H K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
KARNATAKA 576104 India |
| Phone |
9740730283 |
| Fax |
|
| Email |
hkkanha@gmail.com |
|
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Source of Monetary or Material Support
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| Kasturba Hospital, Kasturba Medical College, Manipal - 576104 |
|
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Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Kasturba Hospital, Kasturba Medical College, Manipal - 576104 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Kumar Singhal |
Kasturba Hospital |
Gate No.10, 1st Floor, Department of Radiodiagnosis and Imaging,
kasturba Hospital
Kasturba medical college,
Manipal Udupi KARNATAKA |
8256924087
rahul.dmv@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Manipal |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, |
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Intervention / Comparator Agent
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Inclusion Criteria
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| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical suspicion of chronic suppurative otitis media |
|
| ExclusionCriteria |
| Details |
Congenital ear disease
Trauma and neoplastic growth involving middle ear
Pregnant patients
Granulomatous disease involving the middle ear
Patients who had previously undergone middle ear operation |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| HRCT temporal bone is expected to have a significant role in patients with chronic suppurative otitis media |
outcome will be assessed at the end of the study |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Will be measured in terms of correlation will be between the pre-operative radiological findings and intraoperative findings in chronic suppurative otitis media patients |
Pre-operative and intra-operative Findings are noted and compared at the end of the procedure |
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Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
01/09/2019 |
| 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="15" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NONE YET |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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INTRODUCTION: High resolution computed tomography, provides as direct visual window in the temporal bone providing minute structural details Chronic suppurative otitis media (CSOM) is a long standing inflammation of the middle ear cleft which can cause severe destruction of the middle ear and mastoid, leading to various sequela T TUBOTYMPANIC VARIETY (SAFE) - sequela of acute otitis media, simple perforation of the pars tensa and non - offensive, non bloody discharge. A ATTICO-ANTRAL VARIETY (UNSAFE) - cholesteatoma often arises from a postero-superior pocket of the tympanic membrane or as a attic cholesteatoma. Due to expansion it starts eroding the surrounding structures - Scutum and ossicular chain. An expanding cholesteatoma may invade the antrum and mastoid space, bony facial canal, tegmen and lateral semicircular canal. AIM: T To study the role of HRCT Temporal bone in evaluation of patients with chronic suppurative otitis media (CSOM) OBJECTIVES: To study the radiological findings (HRCT) of the temporal bone in patients with chronic suppurative otitis media (CSOM). To evaluate and determine the efficacy and role of HRCT temporal bone in patients with CSOM by comparing the pre-operative HRCT temporal bone findings with intra-operative findings (gold standard), whenever available. JUSTIFICATION FOR STUDY:
Due to strategic location of the tympano-mastoid compartment separated from the middle and posterior cranial fossa by thinnest of bony partitions, otitis media has the potential for intracranial extension. HRCT is a guide to the nature of the disease (destructive/non-destructive), potential dangers and possible complications and this information can assist the surgeon in the choice of surgery to be performed (simple or radical mastoidectomy, with or without tympanoplasty). As it is important to recognize the disease early to adopt a surgical procedure, to save the patient from loss of hearing and to prevent the grave intracranial complications, advising the patients a routine HRCT prior to surgery can be justified. It can predict the outcome of the surgery and also helps in discussing these possibilties with the patient. POTENTIAL RISKS AND BENEFITS: Risks: Nil Benefits:A HRCT temporal bone scan is useful for planning the surgical approach, determining the extension and helps to reduce postoperative risks. Patients will be benefited by diagnosing the extent and in evaluating the prognosis and planning treatment
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