Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard oral nutritional supplements |
|
| Immunonutrition | Experimental | Oral nutritional supplements with immunonutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutritional supplement with inmmunonutrition | Dietary Supplement | Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From surgery until 90 days post-hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (Kg) | Weight of the patient at each visit | From preoperative evaluation until 90 days after hospital discharge |
| Height (cm) | Height of the patient at each visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy/ethical restrictions, as they contain information that could compromise the privacy of research participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard oral nutritional supplement | Dietary Supplement | Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition |
|
| From preoperative evaluation until 90 days after hospital discharge |
| BMI (Kg/m2) | Body mass index of the patients calculated using weight and height | From preoperative evaluation until 90 days after hospital discharge |
| Weight loss (%) | Percentage of weight loss from the preoperative baseline weight of the patient | 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. | 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. | 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. | 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. | 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. | From preoperative evaluation until 90 days after hospital discharge |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided