Multicenter RCT on Effects of Preoperative Immunonutrition on Patients Undergoing Elective Colorectal Surgery for Neoplasm: Changes in Adipose Tissue Inflammation and Correlation With Surgical Outcome for Future ERAS Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 主要终点
- Surgical site infection (SSI)
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.
Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.
The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
- •20 to 85 years old, with no difficulties in oral intake
- •BMI ranging from 18 to 40.
排除标准
- •emergency surgery,
- •converted procedures,
- •major intraoperative complications,
- •concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
- •synchronous cancer,
- •previous bowel resections or bariatric surgery,
- •presence of preoperative stoma.
结局指标
主要结局
Surgical site infection (SSI)
时间窗: 30 days after the surgical procedure
Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.
次要结局
- Anastomotic leakage (AL)(30 days after the surgical procedure)
- grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)(at the time of tissue analysis, usually 1 month after surgery)
- Length of stay (LOS)(at patients' discharge)
- Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)(at the time of tissue analysis, usually 1 month after surgery)
- Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)(at the time of tissue analysis, usually 1 month after surgery)
研究者
Giuseppe Nigri, MD, PhD, FACS
Professor
University of Roma La Sapienza