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

NCT07506187 | Completed

• 1 other identifier: PEIBA 0655-N-22
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Arginine-enriched oral nutritional supplementation; Immunonutrition; High-protein, high-calorie formula; Nutritional screening and diagnosis; Length of hospital stay

Outcome Measures

Primary Outcomes (12)

• Presence of Postoperative Complications

  This dependent variable tracks whether a patient experiences any medical or surgical complications following colorectal surgery. It is recorded as a binary outcome (Yes/No) and serves as the main indicator of the intervention's success in improving patient recovery.

  At 24 hours after the procedure and 30 days after surgery.

• Surgical Site Infection

  An infection occurring at the site of the surgical incision or in the surrounding tissues within the first 30 to 90 days after the procedure. It is assessed using standardized clinical criteria and recorded as Yes or No.

  From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.

• Postoperative Intestinal Ileus

  A temporary failure of the intestines to resume normal muscle contractions (peristalsis) after surgery, which prevents the passage of food and waste. It is recorded as Yes or No based on clinical observation.

  At 24 hours after the procedure and 30 days after surgery.

• Intra-abdominal Collection (Abscess)

  A localized accumulation of pus within the abdominal cavity. It is confirmed by the presence of bacteria in a clinical smear or by positive growth in a bacterial culture. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Intestinal Ischemia

  A serious condition occurring when blood flow to the intestines is reduced due to a blockage in a blood vessel, typically an artery, which can lead to tissue damage or death. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Intestinal Evisceration

  The protrusion of internal abdominal organs (such as the intestines) through a surgical wound that has reopened across all layers of the abdominal wall following a laparotomy. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Bacteremia

  The clinical presence of viable bacteria in the patient's bloodstream, typically identified through blood cultures. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Suture Dehiscence

  The failure or reopening of a surgical wound or an internal connection (anastomosis) where tissues were joined by sutures, allowing the edges to separate. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Phlebitis

  Inflammation of the walls of a vein, which can occur as a complication of intravenous therapy or the surgical process. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Urinary Tract Infection

  An infection occurring in the urinary system (urethra, bladder, or kidneys), common in surgical settings when bacteria enter the urinary tract. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Pneumonia

  An infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus, often caused by bacterial or viral infection during the recovery period. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

• Atelectasis

  A complete or partial collapse of the lung or a section of the lung, which occurs when the small air sacs (alveoli) become deflated, frequently due to increased intra-abdominal pressure during surgery. Dichotomous qualitative variable: Yes / No.

  At 24 hours after the procedure and 30 days after surgery.

Secondary Outcomes (37)

• Biological Sex

  At enrollment (baseline).

• Age

  At enrollment (baseline).

• Clinical Judgment

  At enrollment (baseline).

• Prior Pathologies

  At enrollment (baseline).

• Functional Independence

  At enrollment (baseline) and 30 days after surgery.

Study Arms (3)

Arginine-Enriched Group

EXPERIMENTAL

Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides.

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

Standard Intervention Group

ACTIVE COMPARATOR

Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS).

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

Control Group

NO INTERVENTION

Patients who are well-nourished and do not require specialized supplementation.

Interventions

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

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).

Standard Intervention Group

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

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.

Arginine-Enriched Group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or over.
• Patients due to undergo colorectal surgery.
• Patients who are malnourished or at risk of malnutrition prior to surgery.

You may not qualify if:

• Limitations on oral intake (medical conditions, health status, etc.) or contraindications to oral administration.
• Digestive intolerance or allergy to any of the product's components.
• Emergency colorectal surgery.

Sponsors & Collaborators

• University of Cadiz: lead
• Andalusian Health Service: collaborator
• Universidad de Granada: collaborator

Study Sites (1)

Punta Europa University Hospital

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Colorectal Neoplasms; Malnutrition; Disease

Interventions

Arginine

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; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: October 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)