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CTRI Number  CTRI/2023/09/057729 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 31/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of blood parameters (CRP and Albumin) which serve as a marker for stress and nutritional status, and their role in assessing complications after surgery including duration of hospital stay, reintervention and readmissions after a major abdominal surgery 
Scientific Title of Study   Role of CRP/Albumin ratio in predicting post operative morbidity in Major GI surgeries 
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 Srinidhi S 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  3rd floor, Department of general surgery, Smt Sharda Madhav Pai building, OPD building, kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8197914790  
Fax    
Email  srinidhi1.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh B V  
Designation  Professor & Head of Department  
Affiliation  Kasturba Medical college  
Address  3rd floor, Department of general surgery, Smt Sharda Madhav Pai building, OPD building, kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448654410  
Fax    
Email  dinesh.bv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Kumar Bhat  
Designation  Associate professor & Incharge Head  
Affiliation  Kasturba Medical College 
Address  4th floor, Department of Gastrointestinal surgery, Smt Sharda Madhav Pai building, OPD building, kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9818661868  
Fax    
Email  bharath.bhat@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal, Karnataka 
 
Primary Sponsor  
Name  Dr Srinidhi S 
Address  3rd floor, Department of General Surgery, Kasturba Hospital, Manipal, Karnataka-576104 
Type of Sponsor  Other [SELF] 
 
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 Srinidhi S  Kasturba Hospital   Department of General Surgery; Department of Gastrointestinal surgery; Department of Oncosurgery; Kasturba Hospital, Manipal, Karnataka- 576104
Udupi
KARNATAKA 		 8197914790

srinidhi1.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patient undergoing Major elective gastrointestinal surgery in General
Surgery Department, GIS Department and Onco-surgery Department at KH,
Manipal
2.Patient consenting to be a part of the study.
3.Patient >18 years of age.
4.Patient undergoing neoadjuvant chemotherapy with no evidence of
malnutrition preoperatively 
 
ExclusionCriteria 
Details  1.Patient not willing to participate in the surgery.
2.Patient undergoing emergency GI surgery.
3.Patients undergoing surgeries which are not defined under “major”
criteria ( eg. lap chole ) according to WRHA criteria
4.Patient failing to follow up.
5.Patient <18 years of age.
6.Patient with existing chronic inflammatory conditions.
7.Patient’s with comorbidities causing organ dysfunction
(eg-COPD,CKD) ( ASA grade 3 and above )
8.Patient undergoing albumin infusion pre operatively
9.Patient discharging <48 hours of surgery
10.Patient with operative mortality 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the role of CRP/Albumin ratio in predicting post-operative morbidity.  30 days of postoperative period
 
 
Secondary Outcome  
Outcome  TimePoints 
Relationship between CRP/Albumin ratio and
30 days morbidity.
Need for Intensive Care Unit (ICU) stay.
Length of stay after surgery. 		 Post operative day 3,5,30 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/09/2023 
Date of Study Completion (India) 19/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="6" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  
       To identify patients at risk and to optimize perioperative care, a basic and reliable parameter representing surgical stress is crucial. In clinical settings, postoperative blood C-reactive protein (CRP) levels have been used to assess postoperative inflammatory status. However, the slow kinetics of CRP as a predictor of stress is a major drawback. Peak values are noted only on days 2 or 3 following surgery, which may be too late for early preventive measures. Additionally, albumin is a common nutritional marker and outcome predictor exhibits a rapid response to surgical stress, making it an ideal tool for gauging and predicting a difficult postoperative course. Therefore, the CRP to albumin ratio will accurately reflect the nutritional and inflammatory condition and may act as a marker for the stress response post-surgery and a possible indicator of unfavorable outcomes.
 
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