| 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
|
|
|
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
|
|
|
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
|
|
|
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. |