FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Use of temporal bone CT scan in patients with ear infection 
Scientific Title of Study   Role of high resolution computed tomography temporal bone in evaluation of patients with chronic suppurative otitis media  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
Kasturba Hospital, Kasturba Medical College, Manipal - 576104 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Kasturba Hospital, Kasturba Medical College, Manipal - 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
Secondary Outcome  
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 
 
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" 
Phase of Trial   N/A 
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" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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



 
Close