Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of anastomotic leakage
研究概览
简要总结
Intro: Recent studies on colorectal cancer surgery have been focusing on the role of intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury influence the microbiome composition and possibly induce a shift toward a microbiome dysbiotic state, which predisposes to complicated postoperative course. Microbiome composition changes and enhanced virulence factors may increase the risk of postoperative complications, such as anastomotic leakage (AL), surgical site infection (SSI), and postoperative ileus (PI), which are known to impact on patient's overall survival and cancer recurrence.
Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days.
Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression.
DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. .
For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.
Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years old
- •With histologically confirmed rectal or left colon adenocarcinoma by biopsy material from colonoscopy
- •Having elective colorectal surgery after standardized bowel preparation
- •Affiliated to a social security system
- •Signature of informed consent
排除标准
- •Major surgery 30 days before scheduled colorectal surgery
- •Administration of systemic antibiotic therapy within 30 days prior to planned colorectal surgery
- •Presenting a contraindication to elective colorectal surgery
- •Patient protected by law
- •Pregnant or breastfeeding woman
结局指标
主要结局
Rate of anastomotic leakage
时间窗: 90 days after surgery
detected by imaging techiques (CT scan or MRI)
Rate of prolonged postoperative ileuss
时间窗: 90 days after surgery
detected by clinical observation of the first bowel movement after the surgery
Rate of surgical site infection
时间窗: 90 days after surgery
1)superficial and deep infection:clinical observation of purulent discharge from the wound and/or bacterial staining from the wound 2)organ or deep space infection: imaging techniques (CT, MRI, USS)
次要结局
- microbiome composition(6 months after study start date)
- impact of microbiome metabolites on intestinal epithelial cell proliferation and wound healing(6 months after study start date)
- Expression intensity in cytoplasm of protein ligase HACE1 in tumoral and non-tumoral tissues(3 months after study start date)
- Correlation between detected bacterial OTUs (Operation Taxonomic Units) and the event of reintervention(90 days after surgery)
- impact of microbiome composition on length of hospitalization(at the time of patient's discharge of the hospital)