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NCT Number: 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 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Colorectal Surgery Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Malnutrition Malnutrition or Risk of Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Punta Europa University Hospital

Algeciras, Cadiz, 11207, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Presence of Postoperative Complications

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  2. Surgical Site Infection

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

    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.

  3. Postoperative Intestinal Ileus

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  4. Intra-abdominal Collection (Abscess)

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  5. Intestinal Ischemia

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  6. Intestinal Evisceration

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  7. Bacteremia

    Time frame: At 24 hours after the procedure and 30 days after surgery.

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

  8. Suture Dehiscence

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  9. Phlebitis

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  10. Urinary Tract Infection

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  11. Pneumonia

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

  12. Atelectasis

    Time frame: At 24 hours after the procedure and 30 days after surgery.

    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.

Secondary outcomes

  1. Biological Sex

    Time frame: At enrollment (baseline).

    Classification of the participant as male or female.

  2. Age

    Time frame: At enrollment (baseline).

    The chronological age of the participant measured in years at the time of study entry.

  3. Clinical Judgment

    Time frame: At enrollment (baseline).

    A professional medical assessment of the patient's current health status. Nominal qualitative variable.

  4. Prior Pathologies

    Time frame: At enrollment (baseline).

    A record of pre-existing chronic conditions or previous illnesses. Nominal qualitative variable.

  5. Functional Independence

    Time frame: At enrollment (baseline) and 30 days after surgery.

    A validated tool (Barthel Index) used to measure a patient's performance in activities of daily living (ADLs). It assesses aspects such as eating, washing, dressing, toilet training and mobility. The score ranges from 0 (total dependence) to 100 (total independence).

  6. Handgrip Strength

    Time frame: At enrollment (baseline) and 30 days after surgery.

    A measure of upper body muscle strength and physical function, obtained using a calibrated hydraulic hand dynamometer.

  7. Nutritional status

    Time frame: At enrollment (baseline), 24 hours before the procedure, and 30 days after surgery.

    A standardized screening tool (Malnutrition Universal Screening Tool, MUST) used to identify adults at risk of malnutrition based on Body Mass Index (BMI), unintentional weight loss, and the presence of acute disease.

  8. Nutritional Control Index

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An objective screening score used to identify the risk of malnutrition based on three laboratory parameters: serum albumin, total cholesterol, and total lymphocyte count. Discrete quantitative variable and categorical qualitative variable: risk of malnutrition (no risk, mild, moderate, severe).

  9. Malnutrition Diagnosis

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    A diagnostic framework for malnutrition that requires at least one phenotypic criterion (weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation). Categorical qualitative variable: moderate malnutrition or severe malnutrition.

  10. Fat mass percentage

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.

  11. Fat-free mass percentage

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.

  12. Total body water

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.

  13. Phase Angle

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    A prognostic indicator of cellular health and integrity derived from bioelectrical impedance analysis.

  14. Body Mass Index

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    A calculation of body fat based on the patient's height and weight, expressed in kg/m².

  15. Dietary Intake Percentage

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    A categorical estimation of the amount of prescribed food and supplements consumed, recorded as 25%, 50%, 75%, or 100%.

  16. Intervention Adherence

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    A record of whether the patient consistently followed the prescribed oral nutritional supplement protocol (Yes/No).

  17. Type of diet

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Diet followed by the participant. Nominal qualitative variable.

  18. Hemoglobin

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in g/dL.

  19. Glucose

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  20. Urea

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  21. Creatinine

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  22. Total Cholesterol

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  23. Triglycerides

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  24. Total Proteins

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in g/dL.

  25. Sodium

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  26. Potassium

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in mg/dL.

  27. Total Lymphocyte Count

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Measured in cells/µl.

  28. Serum Albumin

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in g/dL.

  29. Prealbumin

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in mg/dL.

  30. Hospital Length of Stay

    Time frame: From the day of hospital admission for surgery until discharge.

    The total number of days the patient remains hospitalized. Discrete numerical variable.

  31. Healthcare Costs

    Time frame: From the day of hospital admission for surgery until discharge.

    The direct financial costs associated with their care, used to assess the economic impact of the nutritional intervention. Continuous quantitative variable: economic costs (€ and $).

  32. Extracellular water

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.

  33. Intracellular water

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.

  34. Cell mass

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.

  35. Limb muscle mass

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.

  36. Muscle mass index

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.

  37. Moisture content percentage

    Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

    An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Andalusian Health Service
  • Universidad de Granada

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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