Colorectal Surgery
Conditions
Keywords
Colorectal Surgery, Immunonutrition, Enhanced Recovery After Surgery, Preoperative Care, Amino Acids Branched-Chain
Brief summary
Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive. The objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.
Detailed description
Patients undergoing colorectal surgery, experience excessive and persistent catabolism, leading to skeletal muscle depletion, and increased inflammatory and immunological involvement, this results in greater malnutrition, mortality, and postoperative morbidity. Depletion of amino acids leads to an increased inflammatory response and diminished immunity. Guidelines of leading international societies in the field of clinical nutrition recommend the perioperative administration of oral formulas with immunonutrients in these patients. The administration of nutritional supplements known as immunonutrition (fortified with arginine, glutamine, branched-chain amino acids (BCAAs) and omega-3 polyunsaturated fatty acids) before gastrointestinal surgery has been shown to improve clinical outcomes, such as a reduction in post-surgical infectious, reduced risk of anastomotic leakage and fewer days of hospital stay; however, the mechanisms related to these benefits are not conclusive. The aim of the study is to evaluate the effect of preoperative nutritional supplementation for 7 days with a formula enriched with immunonutrients compared to an isocaloric and isoproteic formula, on the plasma concentration of BCAAs in patients undergoing elective colorectal surgery. A randomized, double-blind, controlled trial will be conducted with 63 patients per group. The concentration of BCAAs will be measured prior to the 7 days of nutritional supplementation and will be repeated on the day of the surgical intervention before the procedure. The supplements for both groups will provide 500 calories, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids; the supplement for the intervention group is additionally fortified with immunonutrients. Patients will be instructed to consume the supplement daily for the 7 days prior to the surgical intervention. Patients in both groups will be advised to maintain their usual food intake. The investigators hypothesized that if an oral formula with immunonutrients is administered compared to an isocaloric and isoproteic formula without them for 7 days in the preoperative period in patients undergoing elective colorectal surgery, there will be an increase in the plasma concentration of BCAAs in the intervention group.
Interventions
DIETARY_SUPPLEMENTPreoperative oral immunonutrition formula
Intervention arm will daily receive, for 7 days, a preoperative oral formula with immunonutrients: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, 11 g of lipids, 5.7 g of glutamine, 7 g of arginine, 3.6 g of leucine, 2.7 g of isoleucine, 3.7 g of valine, and 0.35 g of omega 3
DIETARY_SUPPLEMENTPreoperative oral Isocaloric and isoproteic polymeric formula
Control arm will daily receive, for 7 days, an isocaloric and isoproteic preoperative oral formula: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, controlled clinical trial Sample Size: For the sample size calculation, it was considered that patients in the immunonutrition intervention group will have a 21% increase in plasma branched-chain amino acid concentration, as reported in the study by Cangiano C et al. Therefore, considering a type 1 error (α) of 0.05 with one tail, and a type 2 error (β) of 0.20, and using the formula N = 2s² (Zα + Zβ)² / Δ², a sample size of 63 subjects per group is obtained.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both sexes * Over 18 years of age * Scheduled for elective colorectal surgery (Resection and intestinal reconnection) * Obtaining patient consent
Exclusion criteria
* Consumption of nutritional supplements during the 2 weeks prior to patient enrollment * Consumption of additional nutritional supplements during the 7 days corresponding to the study intervention period * Patients diagnosed with chronic kidney disease * Patients diagnosed with hepatic cirrhosis * Documented allergy to any of the ingredients in the formulas under evaluation (milk and/or soy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of branched-chain amino acids | The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure | Plasma concentrations of branched-chain amino acids, expressed in micromoles per liter (µmol/L), will be quantified at two distinct time points during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of albumin | The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure | Serum concentrations of albumin, expressed in grams per deciliter (g/dL), will be quantified at two distinct time points during the study |
| Concentration of high-sensitivity C-reactive protein | The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure | Serum concentrations of high-sensitivity C-reactive protein, expressed in milligrams per deciliter (mg/dL), will be quantified at two distinct time points during the study |
| Mortality | Mortality will be assessed within 30 days post-surgery | The incidence of death within the study population will be recorded and reported throughout the study period following surgery |
| Length of stay | Length of stay will be assessed within 30 days post-surgery | The number of days from the patient's hospital admission to discharge will be recorded and reported during the study period |
| Hospital readmission | Hospital readmission will be assessed within 30 days post-surgery | The necessity for rehospitalization after discharge following surgery will be recorded and reported during the study period |
| Anastomotic dehiscence | Anastomotic dehiscence will be assessed within 30 days post-surgery | Occurrence of anastomotic dehiscence within the study population following surgery |
| Surgical site infection | Surgical site infection will be assessed within 30 days post-surgery | Occurrence of surgical site infection within the study population following surgery |
| Fistula | Fistula will be assessed within 30 days post-surgery | Occurrence of fistula within the study population following surgery |
| Paralytic ileus | Paralytic ileus will be assessed within 30 days post-surgery | Occurrence of paralytic ileus within the study population following surgery |
| Postoperative intestinal obstruction | Postoperative intestinal obstruction will be assessed within 30 days post-surgery | Occurrence of postoperative intestinal obstruction within the study population following surgery |
Countries
Mexico
Contacts
CONTACTAurora E Serralde Zúñiga, MD, PhD
PRINCIPAL_INVESTIGATORAurora E Serralde Zúñiga, MD, PhD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Outcome results
None listed