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Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial

Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240706003
Enrollment
162
Registered
2024-07-06
Start date
2024-07-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Colorectal cancer Colorectal surgery Nutritional supplementation Probiotics Time to bowel movement Time to flatus Length of stay Complications

Interventions

Not having any nutritional supplementation at all ,Nutritional supplementation but lacking the probiotic agent (Nestle Isocal).,Nutritional supplementation with the probiotic agent (Nestle Boost Optim
No Intervention No treatment,Placebo Comparator Dietary Supplement,Active Comparator Dietary Supplement
Arm A,Arm B,Arm C

Sponsors

Nestle Singapore (Pte) Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Time to bowel movement daily, for 30 days Number of days from surgery

Secondary

MeasureTime frame
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

Countries

Singapore

Contacts

Public ContactDedrick Kok Hong Chan

National University Hospital

surckhd@nus.edu.sg91701274

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026