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CTRI Number  CTRI/2024/03/063493 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A observational study to understand the effect of albumin level changes in respect to post surgical complication. 
Scientific Title of Study   A Study For Analysis of Pre And Post Operative Fluctuations In Serum Albumin Levels As Predictor of Abdominal Surgery Related Outcomes At UPUMS Saifai:A Follow Up 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  Atul Kumar 
Designation  Junior Resident 
Affiliation  UPUMS Saifai Etawah 
Address  R.N. 226 Department of General Surgery
Department of General Surgery
Etawah
UTTAR PRADESH
206130
India 
Phone  7895900472  
Fax    
Email  yadavdratul343@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anil Kumar 
Designation  Profesor 
Affiliation  UPUMS Saifai Etawah 
Address  Department of General Surgery UPUMS Saifai
Department of General Surgery
Etawah
UTTAR PRADESH
206130
India 
Phone  9458409337  
Fax    
Email  profanilrims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Atul Kumar 
Designation  Junior Resident 
Affiliation  UPUMS Saifai Etawah 
Address  R.N. 226 Department of General Surgery
Department of General Surgery
Etawah
UTTAR PRADESH
206130
India 
Phone  7895900472  
Fax    
Email  yadavdratul343@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical science Saifai Etawah 
 
Primary Sponsor  
Name  UPUMS Saifai Etawa 
Address  Saifai Etawah pin cod 206130 
Type of Sponsor  Research institution and hospital 
 
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 Atul Kumar  Uttar Pradesh University of Medical Science Saifai Etawah pin 206130 Saifai Etawah  R.N. 226 Department of Surgery
Etawah
UTTAR PRADESH 
7895900472

yadavdratul343@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai,Etawah  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patient who will undergo abdominal surgery. 
 
ExclusionCriteria 
Details  Age below 14 years old and above 70 years old
Patient who got Albumin correction.
Patient with liver cirrhosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Establishment of serum albumin changes with respect to post abdominal surgery outcomes.  Albumin level will be note 24 hour prior operative procedure and after that 24 hour interval with outcomes till post operative day 8 
 
Secondary Outcome  
Outcome  TimePoints 
t will be easy to predict the outcome of surgery related complications
that might help in selection of procedure in pre op period.  
At the time of result. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/03/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Aoife M Ryan et al (2007) The aim of this study was to determine if the absolute albumin level on the first postoperative day was of value in predicting in-hospital complications.  A retrospective study of 200 patients undergoing esophagectomy for malignant disease at St. James Hospital between 1999 and 2005 was performed . Serum albumin concentration on the first postoperative day is a better predictor of surgical outcome than many other preoperative risk factors. It is a low cost test that may be used as a prognostic tool to detect the risk of adverse surgical outcomes.



Gaetan-Romain Joliat  et al(2022) Postoperative complications are frequent after gastrointestinal surgery and early prediction remains an unmet need. Serum albumin shows a rapid decrease after surgery, and this decline (ΔAlb) may reflect the intensity of the surgical stress response and thereby be a predictor of postoperative complications. This study aimed to comprehensively review the available data on ΔAlb in gastrointestinal surgery. PRISMA guidelines were followed to conduct a systematic review of the literature in MEDLINE and Embase. Studies assessing the role of ΔAlb to predict complications after gastrointestinal surgery were included. Alb appeared as a valuable and promising biomarker to anticipate complications after gastrointestinal surgery. Future efforts are needed to determine whether and how ΔAlb may be integrated in clinical practice to guide clinicians in the perioperative management of patients.



"Now in this Study we are going to evaluate incidence of particular complication with respect to change in Albumin level"


 
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