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

Summary

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.

Conditions

• Colorectal Neoplasms

Interventions

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 .

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 .

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia

  lead OTHER

Principal Investigators

• Siti Rahmah Binti Hashim Isa Merican, Dr · Hospital Universiti Sains Malaysia

• Muhammad Faeid BIn Othman, Dr · Hospital Universiti Sains Malaysia

• Manivaasan Pannirselvam, Dr · Hospital Universiti Sains Malaysia

• Nor Syarahani Binti Jusoh, Dr · Hospital Universiti Sains Malaysia

• Wong Pak Kai ( Michael), Dr · Hospital Universiti Sains Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-26

Primary Completion

2024-09-25

Completion

2024-09-25

Countries

• Malaysia

Study Locations