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CTRI Number  CTRI/2025/09/094288 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to Compare how the time of Starting oral Feeding After Surgery Affects Recovery for Small and Large Bowel Operations 
Scientific Title of Study   Evaluate the effect of Early vs Standard Enteral Feeding in cases of small and large bowel surgeries 
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 Yashasvi Trivedi 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru, Medical College, Sawangi, Wardha, Maharashtra, 442001, India

Wardha
MAHARASHTRA
442001
India 
Phone  7016716134  
Fax    
Email  yashasvitrivedi16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Gattani 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru, Medical College, Sawangi, Wardha, Maharashtra, 442001, India

Wardha
MAHARASHTRA
442001
India 
Phone  9373108181  
Fax    
Email  sakshigattani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yashasvi Trivedi 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru, Medical College, Sawangi, Wardha, Maharashtra, 442001, India

Wardha
MAHARASHTRA
442001
India 
Phone  7016716134  
Fax    
Email  yashasvitrivedi16@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India pin code 442001 
 
Primary Sponsor  
Name  ICMR 
Address  The Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India.  
Type of Sponsor  Government funding agency 
 
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 Yashasvi Trivedi  Acharya Vinoba Bhave Rural Hospital  Ward 42-43-44-45-46, Department of General Surgery, Jawaharlal Nehru, Medical College, Sawangi, Wardha, Maharashtra, 442001, India
Wardha
MAHARASHTRA 
7016716134

yashasvitrivedi16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee  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  Early Enteral Feeding  Early enteral feeding to be started within 12-24 hrs after surgery at the rate of 20-50ml/hr until post opetative day 1, starting with sips of water, ors, orange juice, tea and fat free milk, advance to regular diet within the next 24-48 hrs, and increase as tolerated to the target rate on 2nd and 3rd post operative day. 
Comparator Agent  Standard Enteral Feeding  Standard enteral feeding will not be started until resolution of postoperative ileus, i.e. Until the appearance of bowel sounds on auscultation and passage of flatus, then followed by clear liquid diet, followed by regular diet 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Procedures involving the gastrointestinal tract, such as elective bowel resections, colonic or small bowel surgeries, anastomoses (Hand suture/ Stapler)

Adults more than 18 years of age undergoing elective small and large bowel surgeries.

Patient capable of receiving enteral nutrition.

Patients with controlled co-morbidities like DM and HTN. 
 
ExclusionCriteria 
Details  Patients with contraindications to enteral feeding for example, pre-existing malabsorption syndrome.

Patients with serious comorbidities such as severe cardiac anomalies, liver cirrhosis, ascites, CKD, patient unfit for surgery.

Patients requiring immediate postoperative parenteral nutrition and patients on TPN.

Severe gastrointestinal contamination for example significant intra operative peritoneal soiling

Known case of Cancer metastasis, active TB and history of radiation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Early enteral feeding aims to maintain gut integrity, reduce inflammation, and prevent complications like ileus. Delayed enteral feeding may be considered to mitigate potential risks, balancing the benefits of early nutrition with individual patient factors and surgical considerations. The rationale involves optimising recovery while minimising postoperative complications.  15 - 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Standard enteral feeding is better than early enteral feeding, & has better postoperative outcome.  15-30 days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/09/2025 
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="2"
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 - NO
Brief Summary  

A prospective interventional case control study will be conducted for 64 patients of small and large bowel surgeries in a tertiary care centre in central India.

The patients will be randomised alternatively in each group. 

In control group patients, Standard enteral feeding will not be started until resolution of postoperative ileus i.e. until the appearance of bowel sounds on auscultation and passage of flatus, then followed by clear liquid diet, followed by regular diet.

In cases group patients, Early enteral feeding will be started within 12-24 hours after surgery at the rate of 20-50 ml/hour until the first postoperative morning, starting with sips of water, oral rehydration solution, orange juice, tea and fat free milk, advance to regular diet within the next 24 - 48 hours, and increase as tolerated to the target rate on 2nd and 3rd postoperative day.

Intolerance to feeding (usually abdominal distension and vomiting) to be managed by decreasing and discontinuing feeding as required for few hours until clinical resolution.

All the patients are to be monitored clinically and investigations (lab investigations and radiological studies) are to be sent accordingly for vomiting, abdominal distension, length of ileus, tolerance to regular diet, length of hospitalisation, septic complications like pneumonia (fever, leukocytosis, purulent sputum, new pulmonary infiltrates), intra-abdominal abscess, empyema, line sepsis, necrotising fasciitis and wound infection associated with wound dehiscence are considered, diarrhoea i.e. unformed, watery stool occurring for more than 3-4 times for a period of 24 hours.


The timing of enteral feeding post-bowel surgery is crucial due to potential impacts on healing, complications, and patient outcomes. Early enteral feeding aims to maintain gut integrity, reduce inflammation, and prevent complications like ileus. Delayed enteral feeding may be considered to mitigate potential risks, balancing the benefits of early nutrition with individual patient factors and surgical considerations. The rationale involves optimising recovery while minimising postoperative complications. These parameters are taken into consideration along with certain important things like propped up position feeding and feeding tolerated or not.

 
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