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CTRI Number  CTRI/2024/12/078525 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   In this trial we will do a detailed study of clinical aspects of patients diagnosed with inflammatory bowel disease in age group of 60 years and above and to compare these findings with patients diagnosed with inflammatory bowel disease in age group from 18 years to 60 years 
Scientific Title of Study   Clinical characteristics of patients with elderly onset inflammatory bowel disease in a tertiary care hospital in Eastern India  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Souradip Mukherjee 
Designation  Medical Gastroenterology DM Resident 
Affiliation  Institute of Post Graduate Medical Education and Research Kolkata 
Address  5th Floor Ronald Ross Building School of Digestive and Liver Diseases Department of Gastroenterology Institute of Post Graduate Medical Education and Research AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9062063410  
Fax    
Email  souradip270493@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shamik Bannerjee 
Designation  Assistant Professor 
Affiliation  Institute of Post Graduate Medical Education and Research Kolkata 
Address  5th Floor Ronald Ross Building School of Digestive and Liver Diseases Institute of Post Graduate Medical Education and Research AJC Bose Road Kolkata
5 kakeswartala lane post office belur math howrah 711202
Haora
WEST BENGAL
700020
India 
Phone  9903756765  
Fax    
Email  docshamikbanerjy1981@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shamik Bannerjee 
Designation  Assistant Professor 
Affiliation  Institute of Post Graduate Medical Education and Research Kolkata 
Address  5th Floor Ronald Ross Building School of Digestive and Liver Diseases Institute of Post Graduate Medical Education and Research AJC Bose Road Kolkata
5 kakeswartala lane post office belur math howrah 711202

WEST BENGAL
700020
India 
Phone  9903756765  
Fax    
Email  docshamikbanerjy1981@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research 
Address  5th Floor Ronald Ross Building School of Digestive and Liver Diseases Institute of Post Graduate Medical Education and Research Kolkata 700020 
Type of Sponsor  Government 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 Souradip Mukherjee  Institute of Post Graduate Medical Education and Research Kolkata  5th floor Ronald Ross Building School of Digestive and Liver Diseases Institute of Post Graduate Medical Education and Research Kolkata 700020
Kolkata
WEST BENGAL 
9062063410

souradip270493@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Institute of Post Graduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K508||Crohns disease of both small andlarge intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients with complete medical histories and Inflammatory bowel disease confirmed by pathological, radiological, clinical and endoscopic diagnosis.
2.Adult-Onset Inflammatory bowel disease patients with presentation at age 18 years upto 60 years and elderly onset Inflammatory bowel disease patients 60 years and older at the time of presentation.
3.Willingness to provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients with onset of presentation less than 18 years of age.
2. Unclassified IBD.
3. Patients with missing data.
4. Unable to undergo endoscopy due to co-morbidities or an unwell clinical state.
5. Failure to provide consent.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study demographic profile epidemiological factors clinical presentation disease characteristics complications and treatment of elderly onset inflammatory bowel disease patients above 60 years old visiting Outdoor Patient Department and Indoor Patient Department of School of Digestive and Liver Disease (SDLD), Institute of Post Graduate Medical Education and Research (IPGMER), KOLKATA.  At Presentation and at 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare those characteristics of elderly onset inflammatory bowel disease with those of adult-onset inflammatory bowel disease  At presentation and then at 6 months and then at 12 months 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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)   27/12/2024 
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 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  

The objectives of this observational study is to study demographic profile, epidemiological factors, clinical presentation, disease characteristics, complications and treatment of elderly onset inflammatory bowel disease patients above 60 years old visiting Outdoor patient Department and  Indoor Patient Department of School of Digestive and Liver Disease (SDLD), Institute of Post Graduate Medical Education & Research (IPGMER), KOLKATA and to compare those characteristics of elderly onset Inflammatory Bowel Disease with those of adult-onset Inflammatory Bowel Disease. The Study period is 1 year and study population are all patients with confirmed diagnosis of Inflammatory Bowel Disease (established on the basis of ECCO-ESGAR Guidelines [clinical, laboratory, radiological, and pathological]) visiting the Outdoor patient Department and  Indoor Patient Department of School of Digestive and Liver Disease (SDLD), Institute of Post Graduate Medical Education & Research (IPGMER), KOLKATA .Sample Size is 65 elderly onset Inflammatory Bowel Disease patients and 130 Adult-onset Inflammatory Bowel Disease patients. Patients with complete medical histories and Inflammatory bowel disease confirmed by pathological, radiological, clinical and endoscopic diagnosis, adult-Onset Inflammatory bowel disease patients with presentation at age 18 years upto 60 years and elderly onset Inflammatory bowel disease patients 60 years and older at the time of presentation and willingness to provide informed consent to participate in the study are included in the study and patients with onset of presentation less than 18 years of age, unclassified Inflammatory Bowel Disease , patients with missing data ,patients unable to undergo endoscopy due to co-morbidities or an unwell clinical state and those who failed to provide consent are excluded.

 
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