Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.

November 7, 2023 updated by: Manivaasan Pannirselvam, Hospital Universiti Sains Malaysia

A Randomized Controlled Trial on Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.

This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

The main questions it aims to answer are:

  1. Does immunonutrition preoperatively facilitate earlier return of Gastrointestinal function?
  2. Does immunonutrition significantly reduce risk of post-operative surgical site infections?
  3. Does immunonutrition significantly reduce duration of hospital stay in patients undergoing colorectal surgery?

Immunonutrition can be defined as modulation of either the activity of the immune system, or modulation of the consequences of activation of the immune system, by nutrients or specific food items fed in amounts above those normally encountered in the diet.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

Partipicant will be randomised into this two arm and then they will consume the respective arm study material for total of 7 days preoperatively.

Data will be collected in post operative period and will be analysed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is the commonest cancer in Malaysian men and the second most common cancer in Malaysian women, accounting for age standardized rate of 14.8 and 11.1 incidences per 100,000 population respectively.

Oncological colonic resection is one of mainstay treatment modality for colorectal tumour. Major surgery precipitate release of stress hormones, inflammatory mediators and metabolic changes resulting in significant catabolic phenomena. This sequentially imposed significant dysfunction of the overall host homeostasis, defence mechanism and inflammatory response. Hence, the major setbacks of colorectal surgery are delay return of normal bowel physiology state, post-operative complications and prolonged hospital stay. This affects patients physiologically and psychologically.

Traditionally , patients undergo major abdominal surgery will be kept nil per oral for 6 to 12 hours prior to operation. Post operatively, parenteral or enteral fluids given until bowel function returns to normal. Fortunately, the introduction of the Enhanced Recovery After Surgery (ERAS) programs in last decade has led to enhanced in the recovery of patients postoperatively. The main aspects of substantial improvements in the care of postoperative patients include early initiation of oral intake as soon as possible, integration of nutrition support ,metabolic control and early mobilisation.

As nutritional status plays a significant role to influence the clinical outcomes, nutrition support has been widely used for elective colorectal surgery patients. Literature reported that nutritional risk rate of cancer patients to be 26% to 76 %, higher than of general patients.

Immunonutrition has been used as therapeutic options for peri-operative nutritional management in patients undergoing surgery. The nutrients of immunonutrition formula usually include arginine, omega-3 fatty acids, glutamine and nucleotides.

The current international guidelines recommend that patient's with high risk of malnutrition should be given immunonutrition in perioperative period prior to major oncologic surgeries.These guidelines are based on randomized controlled trials demonstrating a reduction in the rate of post-operative complications.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings. It comes in sachet form which mixed with water prior to consumption. Multiple randomised controlled trial supported Oral IMPACT as immunonutrition.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

In nutshell , it is important for proper perioperative nutritional support for patients scheduled for colorectal surgery. It remain as major advantage for successful procedure.

In the light of this guideline investigators aimed to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manivaasan Pannirselvam, Dr
        • Sub-Investigator:
          • Wong Pak Kai ( Michael ), Dr
        • Sub-Investigator:
          • Siti Rahmah Binti Hashim Isa Merican, Dr
        • Sub-Investigator:
          • Muhammad Faeid Bin Othman, Dr
        • Sub-Investigator:
          • Nor Syarahani Binti Jusoh, Ms

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age is at least 18 years old
  2. All cases posted for Laparoscopic elective colorectal surgery

Exclusion Criteria:

  1. Known allergy to milk, fish, and soy.
  2. On fluid restriction
  3. Emergency Surgery
  4. Minor Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Impact
Immunonutrition enriched with omega-3 fatty acids, arginine, nucleotides, and soluble fibre. Main source of protein is arginine and casein.
Dietary supplement: Oral Impact
A serving of 74 gm (containing 309 kcal ) of oral impact mixed with 250 ml of water. Each participant will receive total of 3 servings daily for 7 days pre operatively .
Active Comparator: Nutren Optimum
A balanced nutritional supplement that enhance body natural defence and support recovery during illness.
Dietary supplement: Nutren Optimum
A serving of 66.8 gm ( containing 304 kcal ) of nutren optimum mixed with 300 ml of water.Each participant will receive total of 3 servings daily for 7 days pre operatively .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiology Return of Bowel Function
Time Frame: Through study completion , an average of 1 year
To compare the time of the first flatus and first bowel evacuation between Oral Impact® and Nutren Optimum ® when consumed in the preoperative in those undergoing colorectal surgery.
Through study completion , an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: 30 days post operative period
To associate the difference on post operative surgical site infection in between those consuming Oral Impact® versus Nutren Optimum ® in the preoperative period after colorectal surgery.
30 days post operative period
Length of Hospital Stay
Time Frame: From date of admission until patient is discharged back home or date of death from any cause during admission , whichever come first ,accessed up to 1 year
To study on the differences on duration of hospital stay after colorectal surgery in those consuming Oral Impact® and Nutren Optimum ®
From date of admission until patient is discharged back home or date of death from any cause during admission , whichever come first ,accessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universiti Sains Malaysia

Investigators

  • Study Director: Siti Rahmah Binti Hashim Isa Merican, Dr, Hospital Universiti Sains Malaysia
  • Study Director: Muhammad Faeid BIn Othman, Dr, Hospital Universiti Sains Malaysia
  • Principal Investigator: Manivaasan Pannirselvam, Dr, Hospital Universiti Sains Malaysia
  • Study Director: Nor Syarahani Binti Jusoh, Dr, Hospital Universiti Sains Malaysia
  • Study Director: Wong Pak Kai ( Michael), Dr, Hospital Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

September 25, 2024

Study Completion (Estimated)

September 25, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/23050402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

3 months after Publication

IPD Sharing Access Criteria

Primary Investigator ; Sub-Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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