The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
研究概览
简要总结
Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.
Various studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.
This study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.
详细描述
Based on preliminary data, our working hypotheses are that the gut microbiome plays a fundamental role in postoperative healing and that manipulation of preoperative microbiota using inulin will improve postoperative healing and prevent potential development of anastomotic leaks.
The pilot study aims to evaluate the feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery. The project has two main components, a clinical study, and a translational research. A randomized, multi-center, triple-blind, placebo-controlled clinical trial will be conducted to evaluate the impact of inulin supplementation on the clinical and oncological outcomes of inulin supplementation before elective colorectal oncological surgery. Mucosal, blood and fecal samples of patients with inulin supplementation will be compared with samples of patients without inulin supplementation.
The study objectives are:
- Determine the tolerance of colorectal cancer patients to inulin supplementation before surgery.
- Assess the effect of inulin supplementation on colonic healing and the rate of AL.
- Determine the impact of inulin supplementation on the gut microbiota, the inflammatory markers, and the gut barrier function.
- Assess the effect of inulin supplementation on CRC local and distant recurrence after surgery.
Identification of study participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with a colorectal cancer and who present for elective colorectal surgery
排除标准
- •Emergency surgery for perforation/obstruction.
- •Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).
- •Presence of preoperative ileostomy or colostomy.
- •Intestinal surgery within 4 weeks prior to colonic surgery.
- •Active asthma.
- •Presence of familial adenomatous polyposis.
结局指标
主要结局
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
时间窗: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
The GSRS is a seven-point Likert-type scale with response options ranging from 1 (no discomfort at all) to 7 (very severe discomfort). It includes 15 questions that assess various gastrointestinal symptoms.
Change in the Digestion-associated Quality of Life Questionnaire (DQLQ) before and after treatment.
时间窗: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
The DQLQ is a 9-item questionnaire that uses a seven-point Likert-type scale to assess the impact of gastrointestinal symptoms on quality of life. The response options range from 'never' to 'always'.
次要结局
- Change in fecal calprotectin levels before treatment and after treatment (on the day before surgery).(Stool samples will be collected before treatment and after treatment (on the day before surgery))
- Anastomotic leak rate(Anastomotic leaks will be assessed clinically and, if needed, radiologically evaluated. The incidence of anastomotic leak will include cases that experience this complication during the first 12 weeks after surgery.)
- White blood cell count on post-operative day 3(Blood sample will be collected on post-operative day 3.)
- C-reactive protein (CRP) on post-operative day 3(Blood sample will be collected on post-operative day 3.)
- MUC2 levels in the mucosal sample(The mucosal sample will be collected during surgery.)