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NCT07506187Completed

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
44 (actual)
First submitted
26 Mar 2026
Start date
1 Oct 2022
Primary completion date
30 Jun 2025
Lead sponsor
University of Cadiz
NCT number
NCT07506187

What you commit to

  • Study type: Interventional
  • Participants enrolled: 44
  • From 1 Oct 2022 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergency colorectal surgery.

Other illness

  • 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.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Punta Europa University Hospital
Coordinator of this site? Confirm its status
AlgecirasSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.