| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|