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CTRI Number  CTRI/2025/10/095617 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of corticosteroid on inflammation after emergency surgery 
Scientific Title of Study   Comparison of postoperative inflammation with or without preoperative high dose dexamethasone after emergency laparotomy: A randomised controlled 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  Dr Nancy Rustagi 
Designation  Postgraduate resident 
Affiliation  Maulana Azad Medical College and associated hospitals 
Address  Office of Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  7290910945  
Fax    
Email  nancyrustagi1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandra Bhushan Singh 
Designation  Director Professor and Head of Department 
Affiliation  Maulana Azad Medical College and associated hospitals 
Address  Office of Head of Department, Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandra Bhushan Singh 
Designation  Director Professor and Head of Department 
Affiliation  Maulana Azad Medical College and associated hospitals 
Address  Office of Head of Department, Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated hospitals, Delhi- 110002, India 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated hospitals 
Address  Maulana Azad Medical College campus, 2, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi, 110002 
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 Nancy Rustagi  Lok Nayak Hospital  Surgery emergency OT, 4th floor, Emergency block, LNJP Colony
New Delhi
DELHI 		 07290910945

nancyrustagi1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K35||Acute appendicitis, (2) ICD-10 Condition: K281||Acute gastrojejunal ulcer with perforation, (3) ICD-10 Condition: K45||Other abdominal hernia, (4) ICD-10 Condition: K31||Other diseases of stomach and duodenum, (5) ICD-10 Condition: K56||Paralytic ileus and intestinal obstruction without hernia, (6) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (7) ICD-10 Condition: K65||Peritonitis, (8) ICD-10 Condition: K42||Umbilical hernia, (9) ICD-10 Condition: K43||Ventral hernia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no intervention  Dexamethasone will not be administered before the surgery.  
Intervention  Preoperative dexamethasone administration  Immediately before induction of anaesthesia in emergency laparotomy, 1mg/kg dexamethasone will be administered intravenously to the patient.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting to surgery emergency with acute abdomen 
 
ExclusionCriteria 
Details  Patients with diabetes mellitus
People living with HIV
Patients with chronic steroid usage
Patients with chronic kidney disease
Patients with chronic liver disease
Patients with disseminated malignancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in CRP levels  before and 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Change in IL6 levels  before and 24 hours after surgery 
Percentage of patients developing systemic inflammatory response syndrome  Till post-operative day 7 
Percentage of patients developing surgical site infections  Till post-operative day 30 
Duration of hospital stay in days   Till the time of discharge 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   18/10/2025 
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 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

All patients presenting in Surgery emergency with diagnosis of intestinal obstruction or viscus perforation will be included in the study and randomized into 2 groups- 

Group A: high dose dexamethasone administration, Group B: without dexamethasone administration


The levels of CRP and IL6 will be recorded in preoperative and postoperative period and compared in both groups.

Patients of both the groups will be evaluated for Systemic inflammatory response syndrome, surgical site infection, duration of hospital stay and compared.

 
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