| CTRI Number |
CTRI/2025/01/079022 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Importance of second look endoscopy in patients of GI Bleed after normal endoscopy and colonoscopy: A prospective study. |
|
Scientific Title of Study
|
Importance of second look endoscopy in patients of potential small bowel bleed : A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdullah |
| Designation |
Senior Resident |
| Affiliation |
IPGMER and SSKM |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM
Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09453008887 |
| Fax |
|
| Email |
MAILABDULLAHJNMC@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshaunish Das |
| Designation |
Professor |
| Affiliation |
IPGMER and SSKM |
| Address |
Room no 24, 4th floor Ronald Ross Building, IPGMER and SSKM
Hospital, 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830349787 |
| Fax |
|
| Email |
dockdas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdullah |
| Designation |
Senior Resident |
| Affiliation |
IPGMER and SSKM |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM
Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09453008887 |
| Fax |
|
| Email |
MAILABDULLAHJNMC@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital Kolkata room no 24 Ronald ross IPGMER and SSKM Hospital AJC
Bose Road Kolkata 700020
|
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM
Hospital 244 AJC Bose Road Kolkata |
| 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 Abdullah |
IPGMER and SSKM Hospital |
Endoscopy suits, School of Digestive and Liver Diseases, Gastroenterology Division, IPGMER and SSKM Hospital
Kolkata
WEST BENGAL |
09453008887
MAILABDULLAHJNMC@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IPGMER and |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients of potential small bowel GI bleed will be included. |
|
| ExclusionCriteria |
| Details |
Patients with standard contraindications for UGIE will be exluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in whom small bowel evaluation could have been avoided |
at 12 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Procedure Rates: Number of interventions needed to diagnose etiology of GI Bleed.
Transfusion Rate: Number of units of blood transfusion needed prior to diagnose etiology of GI Bleed.
Recurrence Rate: Number of episodes of GI Bleed over a follow-up period of 6-12 months.
Obscure GI Bleed prevalence: Number of patients not found to have a source of bleeding after standard upper & lower endoscopic examinations, small bowel evaluation with VCE and/or enteroscopy, & radiographic testing
|
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
30/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Previous prospective and
retropesctive studies have revealed that, during evaluation for small bowel
bleeding, 3.5 to ~20% have an attributable lesion within the reach of the upper
and lower gastro-intestinal endoscope. We wanted to assess the prevalence of
lesions causing GI bleeding, at second-look upper gastrointestinal endoscopy
(UGIE) and/or Colonoscopy, that can avoid the necessity of performing small
bowel evaluation (in form of enteroscopy and/or capsule endoscopy and/or
CT-enterography) in patients presenting with Probable small bowel bleeding, either
overt or occult. |