Colorectal CancerNCT05568316
Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients
A study testing Preoperative Immunonutrition and Perioperative Immunonutrition in people with Colorectal Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Colorectal cancer is among the top three types of cancer that are most common and causes death worldwide.Nutritional support is widely used in elective colorectal surgery patients, as nutritional status is an important factor affecting clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Preoperative Immunonutrition and Perioperative Immunonutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with colorectal cancer,
- from 18 years up to 65 years old,
- To be volunteer,
- Informed written consent
Who cannot join
- Under the age of 18,
- Above the age of 65
- To be pregnant,
- Acute and chronic renal failure, cirrhosis, advanced COPD, mechanical intestinal obstruction, metastasis, presence of sepsis,
- The ejection fraction is below 35%.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri University
Istanbul, Uskudar, 34668
About this study
Official title: Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial
Colorectal cancer is among the top three types of cancer that are most common and causes death worldwide.Nutritional support is widely used in elective colorectal surgery patients, as nutritional status is an important factor affecting clinical outcomes. European Society for Clinical Nutrition and Metabolism (ESPEN, 2016) emphasizes that nutritional supplementation with compounds such as amino acids, arginine, glutamine, and fish oil (omega 3) improves postoperative recovery.
Glutamine; it becomes an essential amino acid under stress. It is an energy substrate for cells such as intestinal mucosal cells and lymphocytes, a material for glutathione synthesis, and a potent antioxidant, which also increases heat shock protein expression. In stressful conditions, arginine is the primary fuel source for T cells and is required for nitric oxide synthesis; therefore, it helps maintain immune function. Omega 3; It plays a role in the treatment of inflammation and improves wound healing. In addition, EPA and DHA increase the immune response by improving lymphocyte function. RNA; They are essential for maturation, proliferation, and function in nearly all biochemical processes, in rapidly proliferating cells such as T cells. studies have shown that immunonutrition (IMN) formulas enriched with biologically active compounds may be more effective in reducing infection complications and shortening postoperative hospital stays.
This study aimed to investigate the additional effects of perioperative compared with preoperative immunonutrition on anthropometric, nutritional, and biochemical parameters, complications, and the length of hospital stay in patients with colorectal cancer.
Read the detailed description
Colorectal cancer is one of the five most common cancer types in men and women worldwide. Cancer malnutrition is seen in patients with colorectal cancer, and this adversely affects the prognosis of the disease. Major operations performed may lead to dysfunction in body homeostasis, impaired defense mechanisms and inflammatory response, increasing the risk of postoperative complications and prolonging hospital stay. Nutritional support products enriched with special compounds such as arginine, glutamine, and omega3 may contribute to the daily energy intake of patients, as well as support the immune system, increase wound healing, and reduce the risk of infection. It is well-documented that preoperative and perioperative compared to no immunonutrition effectively reduce the risk of developing infectious complications and the length of hospital stay. Unless, studies on this subject are very few, especially in our country, Turkey, and their results are contradictory.
The aim of this study is to investigate the additional effects of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
The hypotheses of this study are as follows:
H0: There is no difference between the consumption of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
H1: Perioperative immunonutrition compare to preoperative has a positive effect in improving the anthropometric measurements, nutritional and biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
Primary purpose: To evaluate the effects of IMN on anthropometric measurements, nutritional and biochemical values of participants in groups.
Secondary purpose: To evaluate the effects of IMN on postoperative complications and length of hospital stay in groups.
The study was conducted as a single-blind prospective randomized controlled clinical trial at a single institution, Haydarpasa Numune Training and Research Hospital General Surgery Clinic, Istanbul, Turkey, between November 2020 and October 2021. The participants included consecutive patients undergoing colorectal cancer surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Preoperative Immunonutrition, Perioperative Immunonutrition
- Keywords
- colorectal cancer, Immunonutrition, Nutritional Status
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative ImmunonutritionDietary supplement
Participants consumed oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before surgery.
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period.
Perioperative ImmunonutritionDietary supplement
Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet.
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Preoperative Immunonutrition (Group 1) | Experimental | Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for only 5 days before surgery, in addition to their standard isocaloric diet.
Duration: 5 days (preoperative) Dietary therapy: Standard oral nutrition and IMN product for 5 days before operation.
The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded. Receives: Dietary Supplement: Preoperative Immunonutrition |
| Experimental: Perioperative Immunonutrition (Group 2) | Experimental | Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet.
Duration: 5 days preoperative and 5 days postoperative Dietary therapy: Standard oral nutrition and IMN product for 5 days before and after operation (perioperative).
The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded. Receives: Dietary Supplement: Perioperative Immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Score >3: The patient is at risk for nutrition and a nutrition facility is started Score <3: one should be scanned. If there is a major operation plan, a nutrition plan should also be developed.
Measured: At the beginning of the study (7 days before the operation)
Anthropometric Measurements
Height in meters was measured by researchers at the begining of the study.
Measured: At the beginning of the study (7 days before the operation)
Anthropometric Measurements
Body weight in kilogram was measured by researchers.
Measured: At the beginning of the study (7 days before the operation)
Anthropometric Measurements
Weight and height will be combined to report BMI in kg/m^2
Measured: At the beginning of the study (7 days before the operation)
Anthropometric Measurements
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Measured: At the beginning of the study (7 days before the operation)
Anthropometric Measurements
Body weight in kilogram was measured by researchers.
Measured: 7th day after the operation
Anthropometric Measurements
Weight and height will be combined to report BMI in kg/m^2
Measured: 7th day after the operation
Anthropometric Measurements
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Measured: 7th day after the operation
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Measured: On the operation day (Day 0)
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Measured: On the operation day (Day 0)
Biochemical Measurements
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Measured: On the operation day (Day 0)
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Measured: On the operation day (Day 0)
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's
Measured: On the operation day (Day 0)
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Measured: On the operation day (Day 0)
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Biochemical Measurements
Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Measured: 7th day after the operation
Secondary outcomes (2)
Postoperative Complications of Participants
Infections (such as urinary tract, wound infections) and complications were recorded during the postoperative period.
Measured: After the operation, up to 30 days.
Lenght of Hospital Stay of Participants
The length of patients' hospital stay were recorded during the postoperative period.
Measured: After the operation, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Nov 2020
- Primary completion30 Oct 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- BEDRİYE URAL, Dr, Principal investigator, Saglik Bilimleri UniversitesiElvan YILMAZ AKYUZ, Assoc. Prof., Principal investigator, Saglik Bilimleri UniversitesiCebrail AKYUZ, Assoc. Prof., Principal investigator, Haydarpasa Numune Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568316
- Sponsor's protocol ID
- 2020/151-2879
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fukatsu K. Role of nutrition in gastroenterological surgery. Ann Gastroenterol Surg. 2019 Feb 25;3(2):160-168. doi: 10.1002/ags3.12237. eCollection 2019 Mar.
PubMed 30923785Karimian J, Hadi A, Salehi-Sahlabadi A, Kafeshani M. The Effect of Arginine Intake on Colorectal Cancer: a Systematic Review of Literatures. Clin Nutr Res. 2019 Jul 25;8(3):209-218. doi: 10.7762/cnr.2019.8.3.209. eCollection 2019 Jul.
PubMed 31384599Bharadwaj S, Trivax B, Tandon P, Alkam B, Hanouneh I, Steiger E. Should perioperative immunonutrition for elective surgery be the current standard of care? Gastroenterol Rep (Oxf). 2016 May;4(2):87-95. doi: 10.1093/gastro/gow008. Epub 2016 Apr 14.
PubMed 27081153Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
PubMed 27227930Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
PubMed 27637832Ural B, Yilmaz-Akyuz E, Akyuz C. Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Clinical Trial. Nutr Cancer. 2024;76(6):469-475. doi: 10.1080/01635581.2024.2338607. Epub 2024 Apr 13.
PubMed 38613322
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05568316
- Acronym / sponsor ID
- 2020/151-2879
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, Immunonutrition, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is among the top three types of cancer that are most common and causes death worldwide.Nutritional support is widely used in elective colorectal surgery patients, as nutritional status is an important factor affecting clinical outcomes. European Society for Clinical Nutrition and Metabolism (ESPEN, 2016) emphasizes that nutritional supplementation with compounds such as amino acids, arginine, glutamine, and fish oil (omega 3) improves postoperative recovery.
Glutamine; it becomes an essential amino acid under stress. It is an energy substrate for cells such as intestinal mucosal cells and lymphocytes, a material for glutathione synthesis, and a potent antioxidant, which also increases heat shock protein expression. In stressful conditions, arginine is the primary fuel source for T cells and is required for nitric oxide synthesis; therefore, it helps maintain immune function. Omega 3; It plays a role in the treatment of inflammation and improves wound healing. In addition, EPA and DHA increase the immune response by improving lymphocyte function. RNA; They are essential for maturation, proliferation, and function in nearly all biochemical processes, in rapidly proliferating cells such as T cells. studies have shown that immunonutrition (IMN) formulas enriched with biologically active compounds may be more effective in reducing infection complications and shortening postoperative hospital stays.
This study aimed to investigate the additional effects of perioperative compared with preoperative immunonutrition on anthropometric, nutritional, and biochemical parameters, complications, and the length of hospital stay in patients with colorectal cancer.
Detailed description
Colorectal cancer is one of the five most common cancer types in men and women worldwide. Cancer malnutrition is seen in patients with colorectal cancer, and this adversely affects the prognosis of the disease. Major operations performed may lead to dysfunction in body homeostasis, impaired defense mechanisms and inflammatory response, increasing the risk of postoperative complications and prolonging hospital stay. Nutritional support products enriched with special compounds such as arginine, glutamine, and omega3 may contribute to the daily energy intake of patients, as well as support the immune system, increase wound healing, and reduce the risk of infection. It is well-documented that preoperative and perioperative compared to no immunonutrition effectively reduce the risk of developing infectious complications and the length of hospital stay. Unless, studies on this subject are very few, especially in our country, Turkey, and their results are contradictory.
The aim of this study is to investigate the additional effects of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
The hypotheses of this study are as follows:
H0: There is no difference between the consumption of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
H1: Perioperative immunonutrition compare to preoperative has a positive effect in improving the anthropometric measurements, nutritional and biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer.
Primary purpose: To evaluate the effects of IMN on anthropometric measurements, nutritional and biochemical values of participants in groups.
Secondary purpose: To evaluate the effects of IMN on postoperative complications and length of hospital stay in groups.
The study was conducted as a single-blind prospective randomized controlled clinical trial at a single institution, Haydarpasa Numune Training and Research Hospital General Surgery Clinic, Istanbul, Turkey, between November 2020 and October 2021. The participants included consecutive patients undergoing colorectal cancer surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Preoperative Immunonutrition (Group 1) | Experimental | Dietary Supplement: Preoperative ImmunonutritionParticipants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for only 5 days before surgery, in addition to their standard isocaloric diet. Duration: 5 days (preoperative) Dietary therapy: Standard oral nutrition and IMN product for 5 days before operation. The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded. |
| Experimental: Perioperative Immunonutrition (Group 2) | Experimental | Dietary Supplement: Perioperative ImmunonutritionParticipants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet. Duration: 5 days preoperative and 5 days postoperative Dietary therapy: Standard oral nutrition and IMN product for 5 days before and after operation (perioperative). The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with colorectal cancer,
- from 18 years up to 65 years old,
- To be volunteer,
- Informed written consent
Key exclusion criteria (5 listed)
- Under the age of 18,
- Above the age of 65
- To be pregnant,
- Acute and chronic renal failure, cirrhosis, advanced COPD, mechanical intestinal obstruction, metastasis, presence of sepsis,
- The ejection fraction is below 35%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative ImmunonutritionParticipants consumed oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before surgery. The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period. | Dietary supplement | Experimental: Preoperative Immunonutrition (Group 1) |
| Perioperative ImmunonutritionParticipants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet. The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period. | Dietary supplement | Experimental: Perioperative Immunonutrition (Group 2) |
Primary outcome
Nutritional Status
Time frame: At the beginning of the study (7 days before the operation)
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Score >3: The patient is at risk for nutrition and a nutrition facility is started Score <3: one should be scanned. If there is a major operation plan, a nutrition plan should also be developed.
Anthropometric Measurements
Time frame: At the beginning of the study (7 days before the operation)
Height in meters was measured by researchers at the begining of the study.
Anthropometric Measurements
Time frame: At the beginning of the study (7 days before the operation)
Body weight in kilogram was measured by researchers.
Anthropometric Measurements
Time frame: At the beginning of the study (7 days before the operation)
Weight and height will be combined to report BMI in kg/m^2
Anthropometric Measurements
Time frame: At the beginning of the study (7 days before the operation)
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: At the beginning of the study (7 days before the operation)
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Anthropometric Measurements
Time frame: 7th day after the operation
Body weight in kilogram was measured by researchers.
Anthropometric Measurements
Time frame: 7th day after the operation
Weight and height will be combined to report BMI in kg/m^2
Anthropometric Measurements
Time frame: 7th day after the operation
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Biochemical Measurements
Time frame: On the operation day (Day 0)
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: On the operation day (Day 0)
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: On the operation day (Day 0)
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: On the operation day (Day 0)
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: On the operation day (Day 0)
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's
Biochemical Measurements
Time frame: On the operation day (Day 0)
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Time frame: 7th day after the operation
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
2 secondary outcomes
Postoperative Complications of Participants
Time frame: After the operation, up to 30 days.
Lenght of Hospital Stay of Participants
Time frame: After the operation, up to 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 30923785Fukatsu K. Role of nutrition in gastroenterological surgery. Ann Gastroenterol Surg. 2019 Feb 25;3(2):160-168. doi: 10.1002/ags3.12237. eCollection 2019 Mar.
- Background: PubMed 31384599Karimian J, Hadi A, Salehi-Sahlabadi A, Kafeshani M. The Effect of Arginine Intake on Colorectal Cancer: a Systematic Review of Literatures. Clin Nutr Res. 2019 Jul 25;8(3):209-218. doi: 10.7762/cnr.2019.8.3.209. eCollection 2019 Jul.
- Background: PubMed 27081153Bharadwaj S, Trivax B, Tandon P, Alkam B, Hanouneh I, Steiger E. Should perioperative immunonutrition for elective surgery be the current standard of care? Gastroenterol Rep (Oxf). 2016 May;4(2):87-95. doi: 10.1093/gastro/gow008. Epub 2016 Apr 14.
- Background: PubMed 27227930Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
- Background: PubMed 27637832Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
- Derived from this study: PubMed 38613322Ural B, Yilmaz-Akyuz E, Akyuz C. Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Clinical Trial. Nutr Cancer. 2024;76(6):469-475. doi: 10.1080/01635581.2024.2338607. Epub 2024 Apr 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BEDRİYE URAL, Dr principal investigator
Saglik Bilimleri Universitesi
Elvan YILMAZ AKYUZ, Assoc. Prof. principal investigator
Saglik Bilimleri Universitesi
Cebrail AKYUZ, Assoc. Prof. principal investigator
Haydarpasa Numune Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Immunonutrition and Perioperative Immunonutrition in people with Colorectal Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Status (time frame: At the beginning of the study (7 days before the operation)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568316, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.