The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the feasibility of patients' recruitment
研究概览
简要总结
The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates.
The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection.
Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.
The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.
详细描述
No more details required.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained.
- •Between 18 to 90 years old inclusive.
- •Group 1 (colorectal cancer patients)
- •Patients with colorectal cancer confirmed with pathology results.
- •Oncological colon and / or rectal resection planned and performed by a surgeon from the digestive surgery department of the CHUM.
- •Group 2 (anastomotic leak patients)
- •Patients with colorectal cancer confirmed with pathology and / or patients with inflammatory bowel disease.
- •Patients who underwent colonic and / or rectal surgical resection, complicated by an anastomotic leak in the postoperative period.
- •Group 3 ("healthy" patients)
- •Patients with uncomplicated hernia pathology assessed externally in anticipation or after hernia repair surgery that does not involve gastrointestinal resection.
- •Patients with no history of colorectal neoplasia or surgical resection of the gastrointestinal tract.
- •Group 4 (inflammatory bowel disease patients)
- •Patients with inflammatory bowel disease (IBD), waiting for elective surgery involving gastrointestinal resection.
排除标准
- •Pregnancy.
- •Class of the American Society of Anesthesiologists (ASA)>
- •Chemotherapy and / or pelvic and / or abdominal radiotherapy within 6 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
- •Colonoscopy within 3 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
结局指标
主要结局
Evaluate the feasibility of patients' recruitment
时间窗: 3 months
Evaluate if we can recruit all required patients easily ; 20 patients total and 5 patients per group (Yes or No).
Evaluate the feasibility of fecal samples' analysis
时间窗: 3 months
Evaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).
次要结局
- Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.(6 months)