Colorectal Cancer, Diet, Healthy, Flatus, Ileus Postoperative
Conditions
Keywords
colorectal cancer, colorectal surgery, nutritional supplementation, probiotics, time to bowel movement, time to flatus, length of stay, complications
Brief summary
There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.
Interventions
DIETARY_SUPPLEMENTNestle Isocal
Nestle Isocal
DIETARY_SUPPLEMENTNestle Boost Optimum
Nestle Boost Optimum
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. undergoing elective colorectal cancer surgery in which an oncologic resection is planned 2. age between 21 and 99 years at the time of consent 3. willing to consider oral nutritional supplementation 4. on an early recovery after surgery (ERAS) pathway 5. able to provide informed consent
Exclusion criteria
1. patients with known contraindications to probiotic use 2. patients undergoing emergency surgery 3. taking any other form of probiotics 4. taking oral antibiotics within 7 days of commencement of study 5. vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to bowel movement | 0 - 14 days | This records the number of days from the day of surgery before the first bowel movement was experienced by the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to flatus | 0 - 14 days | This records the number of days from the day of surgery before the first flatus was experienced by the patient. |
| Adverse events | From commencement of the intervention to 30 days after surgery | Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications |
| Infective complications | From date of surgery to 30 days after surgery | Any infective complications which may occur in the postoperative period. |
| Length of hospital stay | 0 - 14 days | This records the number of days following surgery before the patient is discharged. |
Countries
Singapore
Contacts
Primary ContactDedrick Chan, MBBS, DPhil
Outcome results
None listed