Colorectal Cancer, Colorectal Surgery
Conditions
Keywords
Colorectal cancer, Colorectal surgery, Oral Nutritional Supplementation
Brief summary
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.
Detailed description
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.
Interventions
OTHERDiet Optimization (DO)
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.
DIETARY_SUPPLEMENTOral Nutritional Supplement (ONS)
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).
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants aged more than 18 years old. * Histological diagnosis of colorectal adenocarcinoma. * Participants scheduled for elective minimally invasive colorectal resection. * Participants with a preoperative MUST score equal to or below 2.
Exclusion criteria
* Any condition that, in the opinion of the investigator, may interfere with the study procedures. * Emergent surgery. * Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study. * Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection). * Participants with preoperative MUST score \> 2. * Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 30 days from surgery | The rate of postoperative complications occurring within 30 days from surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative septic complications | 30 days from surgery | 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 |
| Comprehensive Complication Index (CCI) | 30 days from surgery | 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). |
| Length of hospital stay | 30 days from surgery | The median length of hospital stay calculated in days from the day after surgery until the day of discharge |
| Hospital readmission | 30 days from surgery | The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery |
| Sarcopenia | Six months after surgery | 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. |
| Normal weight | 60 days after surgery | 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. |
| Mini Nutritional Assessment (MNA) score | 60 days after surgery | 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). |
| EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score | 60 days after surgery | 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). |
| Proctitis | Six months after surgery | 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 |
Countries
Italy
Contacts
CONTACTAnnalisa Maroli, PhD
CONTACTStefano De Zanet, MS
PRINCIPAL_INVESTIGATORAntonino Spinell, MD, PhD
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy
Outcome results
None listed