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
Trial tests if a special protein drink helps surgery patients recover
Plain English Summary
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 is a Not Applicable clinical trial sponsored by University of Cadiz studying Colorectal Cancer, Malnutrition or Risk of Malnutrition, Colorectal Surgery. This study tests if a special drink with protein, arginine, and other nutrients can help prevent problems after colon or rectal surgery. It's for adults who are malnourished or at risk of malnutrition and are scheduled for colon or rectal surgery. Participants will receive either the special drink or a standard protein drink before and after surgery, and will have several check-ups. Alternatives include standard nutritional support and following doctor's advice on diet and recovery. The trial aims to enroll 44 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older. Individuals scheduled for planned colon or rectal surgery. People who are currently malnourished or are likely to become malnourished. Cannot join if you have trouble eating or drinking, are allergic to the drink's ingredients, or need emergency surgery. This trial is studying Colorectal Cancer, Malnutrition or Risk of Malnutrition, Colorectal Surgery, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if the special drink reduces the occurrence of problems like infections or wound opening after surgery, and if it shortens hospital stays. The specific primary outcome measures are: Presence of Postoperative Complications (At 24 hours after the procedure and 30 days after surgery.); Surgical Site Infection (From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.); Postoperative Intestinal Ileus (At 24 hours after the procedure and 30 days after surgery.); Intra-abdominal Collection (Abscess) (At 24 hours after the procedure and 30 days after surgery.); Intestinal Ischemia (At 24 hours after the procedure and 30 days after surgery.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to find a way to reduce complications and improve recovery for malnourished patients undergoing colorectal surgery, a common and often challenging procedure. This research targets Colorectal Cancer, Malnutrition or Risk of Malnutrition, Colorectal Surgery, where improved treatment options are needed.
Investor Insight
This trial focuses on a specific nutritional intervention for a defined surgical population, suggesting a potential for improved patient outcomes and reduced healthcare costs, which could be of intere
Is This Trial Right for Me?
Ask your doctor if this trial is right for you and what the potential benefits and risks are. Understand that you will receive either a standard or a special nutritional supplement and will have regular medical check-ups. Be prepared for multiple follow-up visits to monitor your health and recovery. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 44 participants
Interventions
- DIETARY_SUPPLEMENT: Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent — 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).
- DIETARY_SUPPLEMENT: Atémpero®: An ONS enriched with arginine with no generic equivalent — 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 20
Primary Outcomes
- Presence of Postoperative Complications (At 24 hours after the procedure and 30 days after surgery.)
- Surgical Site Infection (From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.)
- Postoperative Intestinal Ileus (At 24 hours after the procedure and 30 days after surgery.)
- Intra-abdominal Collection (Abscess) (At 24 hours after the procedure and 30 days after surgery.)
- Intestinal Ischemia (At 24 hours after the procedure and 30 days after surgery.)
Secondary Outcomes
- 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.)
Full Eligibility Criteria
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.
Trial Locations
- Punta Europa University Hospital, Algeciras, Cadiz, Spain
Frequently Asked Questions
What is clinical trial NCT07506187?
NCT07506187 is a Not Applicable INTERVENTIONAL study titled "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." It is currently completed and is sponsored by University of Cadiz. The trial targets enrollment of 44 participants.
What conditions does NCT07506187 study?
This trial investigates treatments for Colorectal Cancer, Malnutrition or Risk of Malnutrition, Colorectal Surgery. The primary condition under study is Colorectal Cancer.
What treatments are being tested in NCT07506187?
The interventions being studied include: Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent (DIETARY_SUPPLEMENT), Atémpero®: An ONS enriched with arginine 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).
What does Not Applicable mean for NCT07506187?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07506187?
This trial is currently "Completed." It started on 2022-10-01. The estimated completion date is 2025-07-31.
Who is sponsoring NCT07506187?
NCT07506187 is sponsored by University of Cadiz. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07506187?
The trial aims to enroll 44 participants. The trial status is completed.
How is NCT07506187 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07506187?
The primary outcome measures are: Presence of Postoperative Complications (At 24 hours after the procedure and 30 days after surgery.); Surgical Site Infection (From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.); Postoperative Intestinal Ileus (At 24 hours after the procedure and 30 days after surgery.); Intra-abdominal Collection (Abscess) (At 24 hours after the procedure and 30 days after surgery.); Intestinal Ischemia (At 24 hours after the procedure and 30 days after surgery.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07506187 being conducted?
This trial is being conducted at 1 site, including Algeciras, Cadiz (Spain).
Where can I find official information about NCT07506187?
The official record for NCT07506187 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07506187. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07506187 testing in simple terms?
This study tests if a special drink with protein, arginine, and other nutrients can help prevent problems after colon or rectal surgery. It's for adults who are malnourished or at risk of malnutrition and are scheduled for colon or rectal surgery.
Why is this trial significant?
This trial matters because it aims to find a way to reduce complications and improve recovery for malnourished patients undergoing colorectal surgery, a common and often challenging procedure.
What are the potential risks of participating in NCT07506187?
The main risks are related to the nutritional supplements themselves, such as digestive upset or allergic reactions, though none were identified in the study description. Potential complications from surgery itself, such as infection or delayed healing, are being studied, but the supplements aim to reduce these. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07506187?
Ask your doctor if this trial is right for you and what the potential benefits and risks are. Understand that you will receive either a standard or a special nutritional supplement and will have regular medical check-ups. Be prepared for multiple follow-up visits to monitor your health and recovery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07506187 signal from an investment perspective?
This trial focuses on a specific nutritional intervention for a defined surgical population, suggesting a potential for improved patient outcomes and reduced healthcare costs, which could be of intere This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either the special drink or a standard protein drink before and after surgery, and will have several check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Colorectal Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.