The Role of Arginine in Oral Nutritional Supplementation in Preventing or Reducing Complications Following Colorectal Surgery in Patients Who Are Malnourished or at Risk of Malnutrition

Summary

The goal of this randomized controlled trial is to evaluate the role of a high-calorie, high-protein oral nutritional supplement enriched with arginine in the prevention or reduction of post-surgical complications in adult patients undergoing scheduled colorectal surgery who are malnourished or at risk of malnutrition.

The main questions it aims to answer are:

* Does the administration of an arginine-enriched enteral formula decrease the occurrence of post-surgical complications compared to a standard high-protein, high-calorie formula?
* Does the use of an arginine-enriched formula reduce the length of hospital stay and associated healthcare costs?

Researchers will compare a high-protein, high-calorie oral nutritional supplement (ONS) enriched with arginine, omega-3, and nucleotides (Atémpero®) to a standard high-protein, high-calorie ONS without arginine (Diaba plus®) to see if the arginine-enriched formula significantly reduces postoperative complications, such as surgical site infections and dehiscence, as well as the duration of hospital stay.

Participants will:

* Undergo a comprehensive nutritional and clinical assessment, including body composition analysis via bioelectrical impedance and handgrip strength tests.
* Receive individualized oral nutritional supplementation (either the arginine-enriched formula or the standard formula) as part of their preoperative preparation.
* Participate in five follow-up visits (baseline, 24 hours pre-surgery, 24 hours post-surgery, 5 days post-surgery, and 30 days post-surgery) for anthropometric, biochemical, and clinical monitoring.

Conditions

• Colorectal Cancer
• Malnutrition or Risk of Malnutrition
• Colorectal Surgery

Interventions

DIETARY_SUPPLEMENT

Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent

It is a complete high-protein, high-calorie formula containing a blend of fibre, indicated for malnourished patients with stress-induced hyperglycaemia and/or diabetes who have increased protein and/or energy requirements. No risks have been identified during the administration of this formula. It is available in 200 mL bottles (vanilla, cocoa and coffee flavours).

DIETARY_SUPPLEMENT

Atémpero®: An ONS enriched with arginine with no generic equivalent

It is a complete, high-protein, high-calorie formula containing a fibre blend enriched with omega-3, L-arginine and nucleotides, and providing vitamin C and zinc. This formula is specifically designed for malnourished patients with wounds or in preparation for surgery. No risks have been identified during the administration of this formula, and it is in line with guidelines for the management of malnourished patients with wounds or those due to undergo colorectal surgery. It is available in a 200 mL format (vanilla flavour). The nutritional information is provided below.

Sponsors & Collaborators

• Andalusian Health Service

  collaborator OTHER_GOV

• Universidad de Granada

  collaborator OTHER

• University of Cadiz

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2025-06-30

Completion

2025-07-31

Countries

• Spain

Study Locations