| CTRI Number |
CTRI/2026/01/100112 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Omega 3 fatty acids in surgery and inflammation |
|
Scientific Title of Study
|
Peri operative Omega 3 fatty acids for surgery induced SIRS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NK Vinod |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Shankara Cancer Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Sri Shankara Cancer Hospital and Research Centre
1st Cross
Shankara Mutt premises
Basavanagudi
Bangalore
KARNATAKA
560001
India |
| Phone |
09980761214 |
| Fax |
|
| Email |
nkvinod@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NK Vinod |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Shankara Cancer Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Sri Shankara Cancer Hospital and Research Centre
1st Cross
Shankara Mutt premises
Basavanagudi
Bangalore
KARNATAKA
560001
India |
| Phone |
09980761214 |
| Fax |
|
| Email |
nkvinod@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NK Vinod |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Shankara Cancer Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Medicine
Sri Shankara Cancer Hospital and Research Centre
1st Cross
Shankara Mutt premises
Basavanagudi
Bangalore
KARNATAKA
560001
India |
| Phone |
09980761214 |
| Fax |
|
| Email |
nkvinod@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Shankara Cancer Hospital and Research Centre, 1st cross, shankarapuram, basavanagudi, chamrajpet, banagalore ,karnataka, india.
pin- 560004 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
Sri Shankara Cancer Hospital and Research Centre, 1st cross, shankarapuram, basavanagudi, chamrajpet, banagalore ,karnataka, india.
pin- 560004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| N K VINOD |
SRI SHANKRA CANCER HOSPITAL AND RESEARCH CENTER |
1ST CROSS
SHANKARA MATT PREMISES, BASAVANAGUDI
Bangalore
KARNATAKA |
9980761214
nkvinod@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SHANKARA CANCER HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Omega 3 fatty acids |
Study group will be administered O3FA in the dose of 0.2mg/kg/day on day prior to surgery
The same dose will be given for 4 days in the postop period also starting from POD1
Pts will be monitored for Procalcitonin, CRP, IL6, S.Alb, RBS on POD1 and 3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Major abdominal cancer surgeries
2. Major head and neck cancer surgeries
|
|
| ExclusionCriteria |
| Details |
Patients with coagulopathies
Patients who are on aspirin which is not stopped at least 3 days before surgery
Patients who have preop infection or sepsis
Patients allergic to fish and seafood
Patients with severe hepatic or renal dysfunction
Patients below 18 yrs and older than 80 years
Patient’s refusal to be infused with fish oil |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Inflammatory markers |
Comparison of Inflammatory markers at Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Return of bowel movements, any SSI, LOSH, postop delirium |
Upto 10 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/11/2026 |
| 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 Yet Recruiting |
| 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
|
Recommendations from ASPEN and ESPEN for periop use of O3FA are limited B recommendation. Significant heterogeneity in results of previous studies Most studies have been done with oral O3FA supplements which have been given for several days pre and postop Reports on cancer patients are mainly from western studies or China Few studies done in India Very few centres in India use O3FA in periop period |