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CTRI Number  CTRI/2025/04/083758 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 30/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Blood cell ratio to predict recovery in gut perforation 
Scientific Title of Study   Neutrophil to lymphocyte ratio as predictor of outcomes in secondary perforation peritonitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asha Rani 
Designation  PGJR 
Affiliation  Panjab University, Chandigarh 
Address  Department of General Surgery , Block D Level 3 Government Medical College And Hospital Sec 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9306133988  
Fax    
Email  asharathee519@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simrandeep Singh 
Designation  Associate Professor 
Affiliation  Panjab University, Chandigarh 
Address  Department Of General Surgery , Block D Level 3 Government Medical College And Hospital Sec 32 Chandigarh 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121501  
Fax    
Email  dr_simrandeep@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Simrandeep Singh 
Designation  Associate Professor 
Affiliation  Panjab University, Chandigarh 
Address  Department Of General Surgery , Block D Level 3 Government Medical College And Hospital Sec 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121501  
Fax    
Email  dr_simrandeep@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Medical College And Hospital Sec 32 Chandigarh 160030 India 
 
Primary Sponsor  
Name  Government Medical College And Hospital 
Address  Sec 32 Chandigarh 160030 India 
Type of Sponsor  Government medical college 
 
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 Asha Rani  Government Medical College and Hospital  Department Of General Surgery , Block D Level 3 Government Medical College And Hospital Sec 32 Chandigarh 160030
Chandigarh
CHANDIGARH 		 9306133988

asharathee519@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  PATIENT WILLING FOR PARTICIPATION IN THE STUDY
ALL PATIENTS PRESENTING IN EMERGENCY WITH FEATURES OF SECONDARY PERFORATION PERITONITIS ON CLINICAL EXAMINATION AND RADIOLOGICAL INVESTIGATIONS 
 
ExclusionCriteria 
Details  1.Patients operated outside Government Medical College and Hospital for secondary perforation peritonitis and later referred to the centre for management of complications.
2. Patients with other causes of raised neutrophil to lymphocyte ratio (NLR), which include malignancy, cardiovascular diseases, acute respiratory distress syndrome, fibrotic liver diseases, person living with HIV, patient with tuberculosis, patient on steroid therapy.
3. Patients with other causes of perforation peritonitis which includes spontaneous bacterial peritonitis and tertiary peritonitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the relationship between NLR and mortality within hospital stay of patients with secondary perforation peritonitis  30 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
1.TO EVALUATE THE RELATIONSHIP BETWEEN NLR AND MORBIDITY
2.To evaluate the incidence of morbidity,which includes
A.Surgical Site Infection and wound dehiscence
B. Respiratory complications/ mechanical ventilatory support
C. Acute kidney injury/ liver failure
D.Postoperative ICU care
E.Anastomotic leak
F.Intraperitoneal abscess  		 30 DAYS 
 
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)   12/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [asharathee519@gmail.com].

  6. For how long will this data be available start date provided 09-12-2024 and end date provided 09-12-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Perforation peritonitis is a common surgical emergency in India, often caused by peptic ulcer perforation, appendicular perforation, trauma, tuberculosis, or enteric perforations. It can lead to severe complications such as sepsis, septic shock, pneumonia, surgical site infections, and organ failure, with a high morbidity rate (~50%) and mortality rate (10–30%). The neutrophil-to-lymphocyte ratio (NLR) is an easily available and cost-effective marker of systemic inflammation, helping predict infection, sepsis, and postoperative complications. NLR, influenced by various factors like anemia, stress, and chronic diseases, is more reliable than CRP in assessing inflammation. This study aims to evaluate NLR as a clinical predictor of outcomes in secondary perforation peritonitis. 
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