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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
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).
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.
Punta Europa University Hospital
Algeciras, Cadiz, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 24 hours after the procedure and 30 days after surgery.
Biological Sex
Classification of the participant as male or female.
Time frame: At enrollment (baseline).
Age
The chronological age of the participant measured in years at the time of study entry.
Time frame: At enrollment (baseline).
Clinical Judgment
A professional medical assessment of the patient's current health status. Nominal qualitative variable.
Time frame: At enrollment (baseline).
Prior Pathologies
A record of pre-existing chronic conditions or previous illnesses. Nominal qualitative variable.
Time frame: At enrollment (baseline).
Functional Independence
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).
Time frame: At enrollment (baseline) and 30 days after surgery.
Handgrip Strength
A measure of upper body muscle strength and physical function, obtained using a calibrated hydraulic hand dynamometer.
Time frame: At enrollment (baseline) and 30 days after surgery.
Nutritional status
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.
Time frame: At enrollment (baseline), 24 hours before the procedure, and 30 days after surgery.
Nutritional Control Index
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).
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Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Malnutrition Diagnosis
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.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Fat mass percentage
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Fat-free mass percentage
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total body water
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Phase Angle
A prognostic indicator of cellular health and integrity derived from bioelectrical impedance analysis.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Body Mass Index
A calculation of body fat based on the patient's height and weight, expressed in kg/m².
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Dietary Intake Percentage
A categorical estimation of the amount of prescribed food and supplements consumed, recorded as 25%, 50%, 75%, or 100%.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Intervention Adherence
A record of whether the patient consistently followed the prescribed oral nutritional supplement protocol (Yes/No).
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Type of diet
Diet followed by the participant. Nominal qualitative variable.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Hemoglobin
Measured in g/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Glucose
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Urea
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Creatinine
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Cholesterol
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Triglycerides
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Proteins
Measured in g/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Sodium
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Potassium
Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Lymphocyte Count
Measured in cells/µl.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Serum Albumin
Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in g/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Prealbumin
Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in mg/dL.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Hospital Length of Stay
The total number of days the patient remains hospitalized. Discrete numerical variable.
Time frame: From the day of hospital admission for surgery until discharge.
Healthcare Costs
The direct financial costs associated with their care, used to assess the economic impact of the nutritional intervention. Continuous quantitative variable: economic costs (€ and $).
Time frame: From the day of hospital admission for surgery until discharge.
Extracellular water
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Intracellular water
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Cell mass
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Limb muscle mass
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Muscle mass index
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Moisture content percentage
An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.
Time frame: At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.