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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diet | Other | Dietary pattern: Standard diet |
|
| High - Fiber diet rich in PUFA | Experimental | High - Fiber diet rich in PUFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary pattern : High-fiber diet rich in PUFA | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of anastomotic leakage | Number of anastomotic leakage | 360 Days from Baseline |
| Surgical site infection | Number of site infection | 360 Days from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiome composition | changes in gut microbiota composition by 16S rRNA gene sequencing | 360 Days from Baseline |
| Serum levels of inflammation markers | Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Ramos Molina | Contact | 968369500 | bruno.ramos@imib.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Research Institute of Murcia (IMIB-Arrixaca) | Recruiting | Murcia | 30120 | Spain |
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open, controlled, randomized clinical trial
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| Dietary pattern: Standard diet | Other | standard nutritional recommendations |
|
| 360 Days from Baseline |
| Length of hospitalization after surgery | Number of days | 360 Days from Baseline |
| Recurrences of CRC after surgery | Number of recurrences | 360 Days from Baseline |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D005231 | Fatty Acids, Unsaturated |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
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