| 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
|
|
|
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
|
|
|
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. |