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

NCT06128798 | Unknown DMC

• 1 other identifier: USM/JEPeM/KK/23050402
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Neoplasms

Keywords

Immunonutrition; Colorectal Cancer; Oral Impact

Outcome Measures

Primary Outcomes (1)

• Physiology Return of Bowel Function

  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 Outcomes (2)

• Surgical Site Infection

  30 days post operative period

• Length of Hospital Stay

  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

Study Arms (2)

Oral Impact

EXPERIMENTAL

Immunonutrition enriched with omega-3 fatty acids, arginine, nucleotides, and soluble fibre. Main source of protein is arginine and casein.

Dietary Supplement: Oral Impact

Nutren Optimum

ACTIVE COMPARATOR

A balanced nutritional supplement that enhance body natural defence and support recovery during illness.

Dietary Supplement: Nutren Optimum

Interventions

Oral Impact DIETARY_SUPPLEMENT

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 .

Oral Impact

Nutren Optimum DIETARY_SUPPLEMENT

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 .

Nutren Optimum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is at least 18 years old
• All cases posted for Laparoscopic elective colorectal surgery

You may not qualify if:

• Known allergy to milk, fish, and soy.
• On fluid restriction
• Emergency Surgery
• Minor Age \< 18 years old

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (12)

• Shaikh SR, Jolly CA, Chapkin RS. n-3 Polyunsaturated fatty acids exert immunomodulatory effects on lymphocytes by targeting plasma membrane molecular organization. Mol Aspects Med. 2012 Feb;33(1):46-54. doi: 10.1016/j.mam.2011.10.002. Epub 2011 Oct 19.

  PMID: 22020145 BACKGROUND

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 RESULT

• Lee SY, Jung MR, Kim CH, Kim YJ, Kim HR. Nutritional risk screening score is an independent predictive factor of anastomotic leakage after rectal cancer surgery. Eur J Clin Nutr. 2018 Apr;72(4):489-495. doi: 10.1038/s41430-018-0112-3. Epub 2018 Feb 19.

  PMID: 29459787 RESULT

• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.

  PMID: 28385477 RESULT

• Chang HR, Bistrian B. The role of cytokines in the catabolic consequences of infection and injury. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):156-66. doi: 10.1177/0148607198022003156.

  PMID: 9586794 RESULT

• Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.

  PMID: 24178185 RESULT

• Grimble RF. Basics in clinical nutrition: Immunonutrition - Nutrients which influence immunity: Effect and mechanism of action. Vol. 4, e-SPEN. Elsevier BV; 2009.

  RESULT

• Xiong L, Teng JL, Botelho MG, Lo RC, Lau SK, Woo PC. Arginine Metabolism in Bacterial Pathogenesis and Cancer Therapy. Int J Mol Sci. 2016 Mar 11;17(3):363. doi: 10.3390/ijms17030363.

  PMID: 26978353 RESULT

• Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.

  PMID: 12464864 RESULT

• Hess JR, Greenberg NA. The role of nucleotides in the immune and gastrointestinal systems: potential clinical applications. Nutr Clin Pract. 2012 Apr;27(2):281-94. doi: 10.1177/0884533611434933. Epub 2012 Mar 5.

  PMID: 22392907 RESULT

• Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.

  PMID: 12352035 RESULT

• Cruzat V, Macedo Rogero M, Noel Keane K, Curi R, Newsholme P. Glutamine: Metabolism and Immune Function, Supplementation and Clinical Translation. Nutrients. 2018 Oct 23;10(11):1564. doi: 10.3390/nu10111564.

  PMID: 30360490 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Siti Rahmah Binti Hashim Isa Merican, Dr

  Hospital Universiti Sains Malaysia

  STUDY DIRECTOR

• Muhammad Faeid BIn Othman, Dr

  Hospital Universiti Sains Malaysia

  STUDY DIRECTOR

• Manivaasan Pannirselvam, Dr

  Hospital Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

• Nor Syarahani Binti Jusoh, Dr

  Hospital Universiti Sains Malaysia

  STUDY DIRECTOR

• Wong Pak Kai ( Michael), Dr

  Hospital Universiti Sains Malaysia

  STUDY DIRECTOR

Central Study Contacts

Manivaasan Pannirselvam, Dr

CONTACT

+60102258767; manivaasan.p@student.usm.my

Wong Pak Kai ( Michael), Dr

CONTACT

+609-7676779; michaelpkwong@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Manivaasan Pannirselvam

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: September 26, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months after Publication
• Access Criteria: Primary Investigator ; Sub-Investigator

Locations

MY (1)