Colorectal Cancer
Conditions
Keywords
Microbiome, Surgery
Brief summary
The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project. Patients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery
Interventions
OTHERDietary pattern : High-fiber diet rich in PUFA
High-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery
OTHERDietary pattern: Standard diet
standard nutritional recommendations
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open, controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-80 years old. * After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery
Exclusion criteria
* Clinical diagnosis of stage IV CRC. * Current gastrointestinal illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.). * Chronic liver or kidney disease. * History of cardiac disease. * Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc). * Alcoholism or illicit drug use. * Antibiotic use within the past 2 months. * Dietary supplement use including pre- or probiotics within the past month. * History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery. * Inflammatory or connective tissue disease (such as lupus, scleroderma, rheumatoid arthritis, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anastomotic leakage | 360 Days from Baseline | Number of anastomotic leakage |
| Surgical site infection | 360 Days from Baseline | Number of site infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut microbiome composition | 360 Days from Baseline | changes in gut microbiota composition by 16S rRNA gene sequencing |
| Serum levels of inflammation markers | 360 Days from Baseline | Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin) |
| Length of hospitalization after surgery | 360 Days from Baseline | Number of days |
| Recurrences of CRC after surgery | 360 Days from Baseline | Number of recurrences |
Countries
Spain
Contacts
Primary ContactBruno Ramos Molina
Outcome results
None listed