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This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.
The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet optimization (DO) | Active Comparator | Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments. |
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| Diet Optimization and Oral Nutritional Supplementation (DO+ONS) | Experimental | Participants in the DO+ONS arm will receive dietary optimization and standardized oral nutritional supplementation designed according to the ESPEN guidelines. The treatment will start 14 days before surgery and will be restored the day after surgery for the following 60 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Optimization (DO) | Other | Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | The rate of postoperative complications occurring within 30 days from surgery | 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative septic complications | The rate of postoperative septic complications occurring within 30 days from surgery. Septic complications are defined according to the criteria proposed by the International Sepsis Definitions Conference and include documented postoperative extra-intestinal infections- such as urinary tract infections and pneumonia-, intra-abdominal septic complications- such as anastomotic leaks, pelvic abscesses, and peritonitis-, surgical site infections, and systemic symptoms of abnormal inflammatory response- such as fever higher than 38°C or C-Reactive Protein (CRP) increase higher than 200 mg/dL for more than two consecutive days |
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Inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 00390282247776 | annalisa.maroli@humanitas.it | |
| Stefano De Zanet, MS | Contact | 00390282244623 | stefano.dezanet@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinell, MD, PhD | Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Rozzano | Milano | 20089 | Italy |
According to the Promoter Standard Operative Procedures, IPD will be uploaded in a public open-access repository (Zenodo). IPD will be made available upon request by sendind an email to biblioteca@humanitas.it
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Randomized controlled
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| Oral Nutritional Supplement (ONS) | Dietary Supplement | ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium). |
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| 30 days from surgery |
| Comprehensive Complication Index (CCI) | The median Comprehensive Complication Index (CCI) computed from all postoperative complications that occurred within 30 days from surgery. The CCI ranges from 0 to 100, where 0 indicates the best outcome (no postoperative complications), and 100 indicates the worst outcome (postoperative complications leading to death). | 30 days from surgery |
| Length of hospital stay | The median length of hospital stay calculated in days from the day after surgery until the day of discharge | 30 days from surgery |
| Hospital readmission | The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery | 30 days from surgery |
| Sarcopenia | The proportion of participants with sarcopenia six months after surgery. Sarcopenia will be assessed from the Skeletal Muscle Index (SMI) computed from the abdominal Computed Tomography (CT) scans collected at screening and 6 months after surgery. SMI less than 7.0 kg/m2 for men and less than 5.5 kg/m2 for women will be considered indicative of sarcopenia. | Six months after surgery |
| Normal weight | The proportion of participants with normo-weight Body Mass Index (BMI) measures at 60 days after surgery. Normal BMI values ranges from 18.5 Kg/m2 and 24.9 Kg/m2. | 60 days after surgery |
| Mini Nutritional Assessment (MNA) score | The median Mini Nutritional Assessment (MNA) score collected 60 days after surgery. The MNA score ranges from 0 (worst possibile nutritional status) to 30 (best possible nutritional status). | 60 days after surgery |
| EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score | The median EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score collected 60 days after surgery. The EQ5D5L score ranges from 0 (worst possible perceived health) to 25 (best possible perceived health). | 60 days after surgery |
| Proctitis | The proportion of participants with clinical signs of active proctitis six months after surgery. Active proctitis will be assessed through rigid or flexible sigmoidoscopy and will be defined by the presence of any of the following findings: friable mucosa with edema, oozing, or ulcerations; bleeding; wall thickening; pseudopolyps; strictures; stenosis; loss of normal curvature; necrosis; perforations; fistula. The severity of proctitis will be classified using the RTOG/EORTC grading system | Six months after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |