NCT07506187

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

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: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Overview This randomized controlled trial (RCT) aims to investigate whether a specific nutritional strategy can improve recovery for adults undergoing scheduled colorectal surgery. Specifically, the study focuses on patients who are malnourished or at risk of malnutrition, a condition affecting 45% to 60% of individuals with colorectal cancer. Malnutrition is a significant concern in surgical settings because it often leads to increased postoperative complications, such as impaired wound healing and higher rates of infection, which ultimately result in longer hospital stays and increased healthcare costs. Background Maintaining an optimal nutritional status is a critical component of modern surgical protocols, including Enhanced Recovery After Surgery (ERAS). While standard high-protein, high-calorie supplements are frequently used, there is ongoing debate within the medical community regarding the added benefits of "immunonutrients"-specialized ingredients like arginine. Arginine is an amino acid that plays a vital role in collagen synthesis and immune system activation, both of which are essential for proper healing and the prevention of infections. This study seeks to determine if adding arginine to a standard nutritional regimen provides superior outcomes compared to standard supplementation alone. Methodology To ensure rigorous results, participants are divided into three distinct groups: * Control Group: Patients who are well-nourished and do not require specialized supplementation. * Standard Intervention Group: Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS). * Arginine-Enriched Group: Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides. All participants undergo a comprehensive clinical and nutritional assessment. This includes bioelectrical impedance analysis to measure body composition (such as muscle mass, fat percentage, and hydration levels) and handgrip strength tests to evaluate physical function and muscle quality. The study follows a structured timeline involving five key evaluation points: * Baseline (Visit 0): Initial diagnosis of malnutrition and the start of the personalized nutritional intervention. * Pre-Surgery (Visit 1): A final check 24 hours before the operation to monitor blood markers and nutritional status. * Early Post-Surgery (Visits 2 \& 3): Monitoring for immediate complications 24 hours and five days after the procedure. * Long-term Follow-Up (Visit 4): A final assessment 30 days after surgery to evaluate overall recovery and quality of life. Key Outcomes and Expected Impact The primary objective is to determine if the arginine-enriched formula significantly reduces surgical site infections, suture dehiscence (the reopening of a surgical wound), and other common postoperative issues. Furthermore, the research team is tracking the duration of hospital stays and associated healthcare expenses to evaluate if specialized nutrition is a cost-effective way to improve patient care. Ultimately, these findings could refine clinical guidelines, helping patients recover more quickly and effectively, thereby improving their overall quality of life.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: Spain