Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after colorectal surgery. However, clinical evidence is heterogeneous, and there are few studies that integrate morbidity outcomes with objective measures of body composition using computed tomography (CT). The objective was to compare immunonutrition versus standard enteral supplementation in surgically treated patients with colorectal cancer, evaluating postoperative complications and changes in body composition. This study was designed as a 1:1 randomized, open-label, two-arm clinical trial: CONTROL group (standard nutritional oral supplements) and IMMUNONUTRITION (immunonutrition oral supplements). Patients were prescribed these daily oral nutritional supplements at least five days before surgery. PRIMARY OUTCOME: Post-surgical complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI). SECONDARY OUTCOMES: Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments. Intragroup changes and the percentage of change between groups were compared. An exploratory analysis was performed in patients with sarcopenia defined by SMMI cut-off points. HYPOTHESIS: It is expected that preoperative immunotherapy may result in less post-surgical complications and better body composition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Post-surgical complications
Complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI).
Time frame: From surgery until 90 days post-hospital discharge
Weight (Kg)
Weight of the patient at each visit
Time frame: From preoperative evaluation until 90 days after hospital discharge
Height (cm)
Height of the patient at each visit
Time frame: From preoperative evaluation until 90 days after hospital discharge
BMI (Kg/m2)
Body mass index of the patients calculated using weight and height
Time frame: From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Percentage of weight loss from the preoperative baseline weight of the patient
Time frame: From preoperative evaluation until 90 days after hospital discharge
MUST (malnutrition universal screening tool) score.
Nutritional assessment by anthropometric methods including weight, weight loss, height, and body mass index, are used to give the MUST (malnutrition universal screening tool) score.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Muscle mass - SMMI (cm2/m2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days adter surgery
Psoas muscle index (cm2/m2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area and index, periabdominal musculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Subcutaneous fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Visceral fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
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