Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial
- Conditions
- Colorectal cancerColorectal surgeryNutritional supplementationProbioticsTime to bowel movementTime to flatusLength of stayComplications
- Registration Number
- TCTR20240706003
- Lead Sponsor
- estle Singapore (Pte) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 162
Patients will be eligible to be recruited into the study if they meet all the following inclusion criteria:
a.undergoing elective CRC surgery in which an oncologic resection is planned
b.age between 21 and 99 years at the time of consent
c.willing to consider oral nutritional supplementation
d.on our institution's enhanced recovery after surgery (ERAS) pathway
e.able to provide informed consent
Exclusion criteria for this study includes:
a.patients with known contraindications to probiotic use
b.patients undergoing emergency surgery
c.taking any other form of probiotics within one month
d.taking oral antibiotics within 7 days of commencement of study
e.vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to bowel movement daily, for 30 days Number of days from surgery
- Secondary Outcome Measures
Name Time Method Time to first flatus daily, for 30 days Number of days from surgery,Length of stay daily, for 30 days Number of days from surgery,Incidence of infective complications daily, for 30 days Incidence of infective complications,Adverse event relating to probiotic use daily, from 7 days before surgery, till 30 days after surgery Incidence of adverse events