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CTRI Number  CTRI/2022/01/039620 [Registered on: 20/01/2022] Trial Registered Prospectively
Last Modified On: 17/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective survey 
Study Design  Other 
Public Title of Study   Contributing factors for readmission among patients after acute pancreatitis 
Scientific Title of Study   A retrospective study to determine the contributing factors for readmission among patients after acute pancreatitis of a tertiary care hospital Udupi district. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Shreenidhi Jogi 
Designation  2nd Year MSc Nursing student 
Affiliation  Manipal College of Nursing 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  8970762744  
Fax    
Email  shreenidhi.jogi1@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mrs Prima JJ DSouza 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Department of Fundamentals of Nursing, Manipal College of Nursing, MAHE, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9986244210  
Fax    
Email  prima.jj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mrs Prima JJ DSouza 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Department of Fundamentals of Nursing, Manipal College of Nursing, MAHE, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9986244210  
Fax    
Email  prima.jj@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
Self 
 
Primary Sponsor  
Name  Mr Shreenidhi Jogi 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shreenidhi Jogi  Kasturba hospital, Manipal  Medical records department, Basement, Women and Child block Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 8970762744

shreenidhi.jogi1@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K85||Acute pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male and female patients aged above 18 years.
2. Patients with any comorbidities such as endocrine disorders, liver disease, kidney and cardiac problems will be included.
3. All patients diagnosed and treated for acute pancreatitis in a selected tertiary care hospital. 4. Admitted within the period of 1st January 2019 to 31st December 2020. 
 
ExclusionCriteria 
Details  nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of readmission and factors contributing to readmission  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  nil 
 
Target Sample Size   Total Sample Size="683"
Sample Size from India="683" 
Final Enrollment numbers achieved (Total)= "700"
Final Enrollment numbers achieved (India)="700" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2022 
Date of Study Completion (India) 31/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

It is a retrospective study. After obtaining administrative permissions and CTRI approval data will be collected through record review method. Medical records of the patients who were treated and who were readmitted for acute pancreatitis from 1st January 2019 to 31st December 2020 will be obtained. Each medical record will be thoroughly reviewed for relevant data. Data will be entered into prepared tools. Descriptive and inferential statistics will be used for data analysis.

 
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