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CTRI Number  CTRI/2025/12/099406 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Blood Test Marker to Predict Risk of Death and Serious Complications After Major Abdominal Surgery 
Scientific Title of Study   Prospective Observational study of the Association between neutrophil to lymphocyte ratio(NLR) and in-hospital mortality and 30-day post-operative outcomes in major abdominal surgery 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rama Krishna Ravula 
Designation  Assistant Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anaesthesia, 3rd floor, Speciality Block Nizams Institute of Medical Sciences, Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9515106104  
Fax    
Email  dr.rk.ravula@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rama Krishna Ravula 
Designation  Assistant Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anaesthesia, 3rd floor, Speciality Block Nizams Institute of Medical Sciences, Punjagutta Hyderabad


TELANGANA
500082
India 
Phone  9515106104  
Fax    
Email  dr.rk.ravula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rama Krishna Ravula 
Designation  Assistant Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anaesthesia, 3rd floor, Speciality Block Nizams Institute of Medical Sciences, Punjagutta Hyderabad


TELANGANA
500082
India 
Phone  9515106104  
Fax    
Email  dr.rk.ravula@gmail.com  
 
Source of Monetary or Material Support  
NIl 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences 
Address  Nizams Institute of Medical Sciences Punjagutta Hyderabad Telangana India 500082 
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 Rama Krishna Ravula  Nizams Institute of Medical Sciences  Operation theatre complex Third floor Specialty Block Nizams Institute of Medical Sciences Punjagutta
Hyderabad
TELANGANA 
9515106104

dr.rk.ravula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age more than 18 years posted for elective abdominal surgey

Patients belonging to American Society of Anaesthesiologist class one two and three 
 
ExclusionCriteria 
Details  Patients undergoing emergency abdominal surgeries
Patients with pre existing hematological conditions
Patients on immunosuppression therapy
Patients in sepsis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
in hospital mortality  30 days from the day of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
30 days post op mortality  30 days after surgery 
 
Target Sample Size   Total Sample Size="565"
Sample Size from India="565" 
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)   01/01/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Major abdominal surgeries, such as gastrointestinal resections, hepatectomies, and colorectal operations, are associated with significant morbidity and mortality despite advances in surgical and anesthetic care. Identifying reliable, inexpensive, and easily measurable predictors of adverse outcomes is essential to improve perioperative risk assessment and patient management.

The neutrophil-to-lymphocyte ratio (NLR), derived from a routine complete blood count (CBC), reflects the balance between inflammation and immune response. Elevated NLR has been linked to poor outcomes in various medical and surgical conditions, including sepsis, cancer, and cardiovascular diseases. However, its prognostic role in major abdominal surgeries remains underexplored.

This study aims to evaluate whether preoperative and postoperative NLR can serve as a cost-effective and reliable predictor of in-hospital and 30-day mortality following major abdominal surgery. If proven effective, NLR could be integrated into preoperative assessments, aiding early identification of high-risk patients and optimizing postoperative care strategies.

This is a prospective observational study. Eligible patients will be recruited preoperatively after obtaining written informed consent. Routine preoperative and postoperative (day 1) blood samples will be analyzed for neutrophil and lymphocyte counts to calculate NLR. No additional invasive procedures will be performed. Clinical, surgical, and outcome data—including type and duration of surgery, intraoperative events, postoperative complications, ICU stay, and mortality—will be collected using a structured data collection form.The primary outcome is in-hospital mortality. Secondary outcomes include 30-day mortality, postoperative complications, ICU admission, and length of hospital stay.


 
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