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

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

NCT ID: NCT06128798

Condition: Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Immunonutrition
Colorectal Cancer
Oral Impact

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Oral Impact
Description: 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 .
Arm group label: Oral Impact

Intervention type: Dietary Supplement
Intervention name: Nutren Optimum
Description: 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 .
Arm group label: Nutren Optimum

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Universiti Sains Malaysia

Address:
City: Kubang Kerian
Zip: 16150
Country: Malaysia

Status: Recruiting

Contact:
Last name: Manivaasan Pannirselvam, Dr

Phone: +60102258767
Email: manivaasan.p@student.usm.my

Contact backup:
Last name: Wong Pak Kai ( Michael ), Dr

Phone: +609-7676779
Email: michaelpkwong@usm.my

Investigator:
Last name: Manivaasan Pannirselvam, Dr
Email: Principal Investigator

Investigator:
Last name: Wong Pak Kai ( Michael ), Dr
Email: Sub-Investigator

Investigator:
Last name: Siti Rahmah Binti Hashim Isa Merican, Dr
Email: Sub-Investigator

Investigator:
Last name: Muhammad Faeid Bin Othman, Dr
Email: Sub-Investigator

Investigator:
Last name: Nor Syarahani Binti Jusoh, Ms
Email: Sub-Investigator

Start date: September 26, 2023

Completion date: September 25, 2024

Lead sponsor:
Agency: Hospital Universiti Sains Malaysia
Agency class: Other

Source: Hospital Universiti Sains Malaysia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06128798