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CTRI Number  CTRI/2025/07/091351 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Enteral ecoimmunonutrition in patients undergoing gastrointestinal cancer surgeries - reduction in postoperative morbidity. 
Scientific Title of Study   Effect of perioperative enteral ecoimmunonutrition on postoperative morbidity in patients undergoing curative gastrointestinal cancer surgeries – a double blind Randomized Controlled Trial 
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 Reshmi Suresh 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Surgical Oncology, All India Institute of Medical Sciences, Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9497680744  
Fax    
Email  reshmi92sbabu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dillip K Muduly 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Surgical Oncology, All India Institute of Medical Sciences, Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9497680744  
Fax    
Email  dillipmuduly@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reshmi Suresh 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Surgical Oncology, All India Institute of Medical Sciences, Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9497680744  
Fax    
Email  reshmi92sbabu@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar PIN 751019 India 
 
Primary Sponsor  
Name  Dr Reshmi Suresh 
Address  Department of Surgical Oncology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, PIN 751019 
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 Reshmi Suresh  AIIMS  Department of Surgical Oncology, AIIMS, Bhubaneswar
Khordha
ORISSA 		 9497680744

reshmi92sbabu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (3) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (4) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (5) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (6) ICD-10 Condition: C20||Malignant neoplasm of rectum, (7) ICD-10 Condition: C218||Malignant neoplasm of overlappingsites of rectum, anus and anal canal, (8) ICD-10 Condition: C220||Liver cell carcinoma, (9) ICD-10 Condition: C221||Intrahepatic bile duct carcinoma, (10) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (11) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Enteral immunonutrition (Maxvida advance formula), Probiotic- Sporolac satchet   Formula- 3scoops/day in water for 5days in preoperative period and 4 days in postoperative period. Sporolac - 1satchet in 10mL water OD 
Comparator Agent  Placebo (Formula- Protinex Diabetic care , satchet Glucon D)  Formula- 3scoops/day in water for 5days in preoperative period and 4 days in postoperative period. Satchet- 1 in 10mL water OD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.All cases of gastrointestinal malignancies undergoing curative elective surgeries in the department of surgical oncology, AIIMS Bhubaneswar.
2.Eastern Cooperative Oncology Group score less than 3.
3.Patients willing to consent for participating in the study.
 
 
ExclusionCriteria 
Details  1.Gastric outlet obstruction, intestinal obstruction undergoing emergency surgery.
2.Sepsis
3.Renal failure and hepatic failure
4.Psychiatric illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Rate of postoperative infectious complications  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Anemia, hypoalbuminemia, inflammatory status.  2 and 4th day of postoperative period 
non infectious complications, duration of postoperative hospital stay, recovery.  30 days 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   04/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - 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 [reshmi92sbabu@gmail.com].

  6. For how long will this data be available start date provided 28-10-2027 and end date provided 28-10-2032?
    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   This study is a randomised double blinded parallel group, single centre trial, comparing the effect of perioperative enteral ecoimmunonutrition vs placebo on postoperative morbidity in 110 patients undergoing curative gastrointestinal cancer surgeries in AIIMS Bhubaneswar , India. The primary outcomes will be postoperative infectious complications in 30 days. The secondary outcomes will be nutritional status, inflammatory status by 4th postoperative day and non infectious complications , recovery by 30 days.   
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