Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Andalusian Health Service | OTHER_GOV |
| Universidad de Granada | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine-Enriched Group | Experimental | Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides. |
|
| Standard Intervention Group | Active Comparator | Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS). |
|
| Control Group | No Intervention | Patients who are well-nourished and do not require specialized supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biological Sex | Classification of the participant as male or female. | At enrollment (baseline). |
| Age | The chronological age of the participant measured in years at the time of study entry. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Punta Europa University Hospital | Algeciras | Cadiz | 11207 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33525881 | Background | Leon Sanz M. [A critical review of the GLIM criteria]. Nutr Hosp. 2021 Apr 12;38(Spec No1):29-33. doi: 10.20960/nh.03558. Spanish. | |
| 34620325 | Background | Gomes-Neto AW, van Vliet IMY, Oste MCJ, de Jong MFC, Bakker SJL, Jager-Wittenaar H, Navis GJ. Malnutrition Universal Screening Tool and Patient-Generated Subjective Global Assessment Short Form and their predictive validity in hospitalized patients. Clin Nutr ESPEN. 2021 Oct;45:252-261. doi: 10.1016/j.clnesp.2021.08.015. Epub 2021 Sep 3. |
Not provided
Not provided
The dataset containing the collected data, whilst ensuring the anonymity of the participants, will be made publicly available upon publication of the results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| At enrollment (baseline). |
| Clinical Judgment | A professional medical assessment of the patient's current health status. Nominal qualitative variable. | At enrollment (baseline). |
| Prior Pathologies | A record of pre-existing chronic conditions or previous illnesses. Nominal qualitative variable. | 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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%. | 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). | 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. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Hemoglobin | Measured in g/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Glucose | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Urea | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Creatinine | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Total Cholesterol | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Triglycerides | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Total Proteins | Measured in g/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Sodium | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Potassium | Measured in mg/dL. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| Total Lymphocyte Count | Measured in cells/µl. | 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. | 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. | 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. | 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 $). | 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. | 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. | 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. | 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. | 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. | 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. | At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery. |
| 23411423 | Background | Osland E, Hossain MB, Khan S, Memon MA. Effect of timing of pharmaconutrition (immunonutrition) administration on outcomes of elective surgery for gastrointestinal malignancies: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):53-69. doi: 10.1177/0148607112474825. Epub 2013 Feb 14. |
| 26693743 | Background | Pan YP, Chang PH, Fan CW, Tseng WK, Huang JS, Chen CH, Chou WC, Wang CH, Yeh KY. Relationship between pre-treatment nutritional status, serum glutamine, arginine levels and clinicopathological features in Taiwan colorectal cancer patients. Asia Pac J Clin Nutr. 2015;24(4):598-604. doi: 10.6133/apjcn.2015.24.4.23. |
| 32355685 | Background | Bistrian BR. The role of preoperative immune modulating nutrition. Hepatobiliary Surg Nutr. 2020 Apr;9(2):221-222. doi: 10.21037/hbsn.2019.09.16. No abstract available. |
| 24651445 | Background | Fujiwara T, Kanazawa S, Ichibori R, Tanigawa T, Magome T, Shingaki K, Miyata S, Tohyama M, Hosokawa K. L-arginine stimulates fibroblast proliferation through the GPRC6A-ERK1/2 and PI3K/Akt pathway. PLoS One. 2014 Mar 20;9(3):e92168. doi: 10.1371/journal.pone.0092168. eCollection 2014. |
| 19770648 | Background | Ellinger S, Stehle P. Efficacy of vitamin supplementation in situations with wound healing disorders: results from clinical intervention studies. Curr Opin Clin Nutr Metab Care. 2009 Nov;12(6):588-95. doi: 10.1097/MCO.0b013e328331a5b5. |
| 28598762 | Background | Liu P, Shen WQ, Chen HL. Efficacy of arginine-enriched enteral formulas for the healing of pressure ulcers: a systematic review. J Wound Care. 2017 Jun 2;26(6):319-323. doi: 10.12968/jowc.2017.26.6.319. |
| 32257915 | Background | Mostafavinia A, Bidram M, Gomi Avili A, Mahmanzar M, Karimifard SA, Sajadi E, Amini A, Hadipour Jahromy M, Ghoreishi SK, Chien S, Bayat M. An improvement in acute wound healing in rats by the synergistic effect of photobiomodulation and arginine. Lab Anim Res. 2019 Dec 11;35:28. doi: 10.1186/s42826-019-0025-x. eCollection 2019. |
| 30841550 | Background | Barchitta M, Maugeri A, Favara G, Magnano San Lio R, Evola G, Agodi A, Basile G. Nutrition and Wound Healing: An Overview Focusing on the Beneficial Effects of Curcumin. Int J Mol Sci. 2019 Mar 5;20(5):1119. doi: 10.3390/ijms20051119. |
| 29848836 | Background | Ma C, Tsai H, Su W, Sun L, Shih Y, Wang J. Combination of arginine, glutamine, and omega-3 fatty acid supplements for perioperative enteral nutrition in surgical patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST): A prospective, randomized, double-blind study. J Postgrad Med. 2018 Jul-Sep;64(3):155-163. doi: 10.4103/jpgm.JPGM_693_17. |
| 25260681 | Background | Hegazi RA, Hustead DS, Evans DC. Preoperative standard oral nutrition supplements vs immunonutrition: results of a systematic review and meta-analysis. J Am Coll Surg. 2014 Nov;219(5):1078-87. doi: 10.1016/j.jamcollsurg.2014.06.016. Epub 2014 Jun 27. No abstract available. |
| 21336438 | Background | Gomez Sanchez MB, Garcia-Talavera Espin NV, Sanchez Alvarez C, Zomeno Ros AI, Hernandez MN, Gomez Ramos MJ, Parra Banos P, Gonzalez Valverde FM. [Perioperative nutritional support in patients with colorectal neoplasms]. Nutr Hosp. 2010 Sep-Oct;25(5):797-805. Spanish. |
| 30817349 | Background | Adiamah A, Skorepa P, Weimann A, Lobo DN. The Impact of Preoperative Immune Modulating Nutrition on Outcomes in Patients Undergoing Surgery for Gastrointestinal Cancer: A Systematic Review and Meta-analysis. Ann Surg. 2019 Aug;270(2):247-256. doi: 10.1097/SLA.0000000000003256. |
| 28468890 | Background | Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3. |
| 34242915 | Background | Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19. |
| 26345703 | Background | Hu WH, Cajas-Monson LC, Eisenstein S, Parry L, Cosman B, Ramamoorthy S. Preoperative malnutrition assessments as predictors of postoperative mortality and morbidity in colorectal cancer: an analysis of ACS-NSQIP. Nutr J. 2015 Sep 7;14:91. doi: 10.1186/s12937-015-0081-5. |
| 31135786 | Background | Gonzalez-Valverde FM, Vicente-Ruiz M, Gomez-Ramos MJ. Risk factors of anastomotic leakage in colon cancer. Cir Cir. 2019;87(3):347-352. doi: 10.24875/CIRU.18000616. |
| 31545068 | Background | Barreiro Dominguez E, Sanchez Santos R, Diz Jueguen S, Pineiro Teijeiro A, Seoane Antelo J, Carrera Dacosta E. [Impact of preoperative oral nutrition therapy in patients undergoing surgery for colorectal cancer]. Nutr Hosp. 2019 Oct 17;36(5):1150-1156. doi: 10.20960/nh.02548. Spanish. |
| 27955850 | Background | Manzanares Campillo MDC, Martin Fernandez J, Amo Salas M, Casanova Rituerto D. [A randomized controlled trial of preoperative oral immunonutrition in patients undergoing surgery for colorectal cancer: hospital stay and health care costs]. Cir Cir. 2017 Sep-Oct;85(5):393-400. doi: 10.1016/j.circir.2016.10.029. Epub 2016 Dec 10. Spanish. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D044342 | Malnutrition |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
Not provided
Not provided