Nutritional Supplementation to Improve Colorectal Cancer Surgery (NUTRICOLOR)
2026年5月13日 更新者：Istituto Clinico Humanitas
Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
190
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Annalisa Maroli, PhD
- 电话号码：00390282247776
- 邮箱：annalisa.maroli@humanitas.it
研究联系人备份
- 姓名：Stefano De Zanet, MS
- 电话号码：00390282244623
- 邮箱：stefano.dezanet@humanitas.it
学习地点
-
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Milano
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Rozzano、Milano、意大利、20089
- Irccs Humanitas Research Hospital
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首席研究员：
- Antonino Spinelli, MD, PhD
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接触：
- Annalisa Maroli, PhD
- 电话号码：00390282247776
- 邮箱：annalisa.maroli@humanitas.it
-
接触：
- Stefano De Zanet, MS
- 电话号码：00390282244623
- 邮箱：stefano.dezanet@humanitas.it
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Diet 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 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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实验性的：Diet Optimization and Oral Nutritional Supplementation (DO+ONS)
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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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.
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative complications
大体时间：30 days from surgery
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The rate of postoperative complications occurring within 30 days from surgery
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30 days from surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative septic complications
大体时间：30 days from surgery
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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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30 days from surgery
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Comprehensive Complication Index (CCI)
大体时间：30 days from surgery
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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).
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30 days from surgery
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Length of hospital stay
大体时间：30 days from surgery
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The median length of hospital stay calculated in days from the day after surgery until the day of discharge
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30 days from surgery
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Hospital readmission
大体时间：30 days from surgery
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The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery
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30 days from surgery
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Sarcopenia
大体时间：Six months after surgery
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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.
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Six months after surgery
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Normal weight
大体时间：60 days after surgery
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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.
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60 days after surgery
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Mini Nutritional Assessment (MNA) score
大体时间：60 days after surgery
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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).
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60 days after surgery
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EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score
大体时间：60 days after surgery
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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).
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60 days after surgery
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Proctitis
大体时间：Six months after surgery
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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
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Six months after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Antonino Spinell, MD, PhD、Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月30日
初级完成 (估计的)
2028年2月28日
研究完成 (估计的)
2028年2月28日
研究注册日期
首次提交
2026年5月4日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CHR1-11-2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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