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.
Patients with a colorectal cancer and who present for elective colorectal surgery
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.
Parallel
Inulin
Dietary supplementInulin is a water soluble non-digestible carbohydrate, and it is available in more than 36,000 species of plants. It is often used as dietary fiber and has obtained the "Generally recognized as safe" status (GRAS) by the Food and Drug Administration (FDA).
Placebo
Other interventionPlacebo control
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
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.
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'.
Anastomotic leak rate
All patients presenting with suspicious clinical features, such as worrisome laboratory results, post-operative fever, or abnormal physical examination findings, will undergo radiological examinations to confirm an anastomotic leak.
White blood cell count on post-operative day 3
The white blood cell count will be monitored on post-operative day 3 to check for signs of infection or inflammation.
C-reactive protein (CRP) on post-operative day 3
The CRP will be monitored on post-operative day 3 to check for signs of infection or inflammation.
Change in fecal calprotectin levels before treatment and after treatment (on the day before surgery).
Changes in fecal calprotectin levels will be monitored to assess colonic inflammation.
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This trial is not recruiting at the moment. You can still explore other options:
