| CTRI Number |
CTRI/2022/09/045409 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to know the degree of impact in patient with acute pancreatitis using BISAP score, RANSON’s criteria and CT severity score and to know the outcome of the patients using these scores |
|
Scientific Title of Study
|
to correlate the severity of acute pancreatitis with regard to BISAP score, RANSON’s criteria and CT severity scores |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR A RANJITHA |
| Designation |
POST GRADUATE GENERAL SURGERY |
| Affiliation |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY ,MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8105243383 |
| Fax |
|
| Email |
Ranjithaamudhavel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HABEEB MOHAMMED |
| Designation |
PROFESSOR |
| Affiliation |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9840161616 |
| Fax |
|
| Email |
HABEEBMOHAMMED043@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR HABEEB MOHAMMED |
| Designation |
PROFESSOR |
| Affiliation |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319
Coimbatore
TAMIL NADU
603319
India |
| Phone |
9840161616 |
| Fax |
|
| Email |
HABEEBMOHAMMED043@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319 |
|
|
Primary Sponsor
|
| Name |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUE OF MEDICAL SCIENCES |
| Address |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319 |
| Type of Sponsor |
Private 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 A RANJITHA |
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES |
SURGICAL WARD, CASUALTY
DEPARTMENT OF GENERAL SURGERY
MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES
KANCHEEPURAM
PINCODE-603319
Kancheepuram
TAMIL NADU |
8105243383
Ranjithaamudhavel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, MELMARUVATHUR ADHIPARASHAKTHI INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)age >15years in both sexes.
2)Characteristic abdominal pain.
3)Increased levels of Serum amylase and/or lipase 3 times the normal value.
4)Ultrasonography of the abdomen demonstrating changes showing acute pancreatitis.
|
|
| ExclusionCriteria |
| Details |
1) Proven cases of chronic pancreatitis.
2) Age <15 years in both sexes.
3) Hereditary pancreatitis
4) Patient with co-morbidities like COPD, renal impairment, immunosuppressive state, CAD.
5) Pancreatic abscess.
6) Pancreatic pseudocyst
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the severity of acute pancreatitis with regard to various scores. |
till time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict prognosis and outcome of acute pancreatitis with regard to the scores observed. |
till time of discharge |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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)
|
15/09/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil
will be published after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Ranjithaamudhavel@gmail.com].
- For how long will this data be available start date provided 19-08-2022 and end date provided 19-08-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to correlate the
severity of acute
pancreatitis with regard
to BISAP, RANSONS, CT SEVERITY scores and to determine the prognosis and outcome of acute pancreatitis with regard to the scores observed.
|