Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial.
Dedrick Kok Hong Chan, Bei En Siew, Jerrald Lau...
https://pubmed.ncbi.nlm.nih.gov/39972354Actively Recruiting
Led by National University Hospital, Singapore · Updated on 2024-06-13
162
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating whether giving probiotics around the time of surgery can help reduce the rates of postoperative ileus, a condition where the bowel doesn't work properly after surgery, in patients undergoing colorectal cancer surgery. Previous studies and meta-analyses have shown that probiotics may speed up the return of bowel function and reduce symptoms like abdominal bloating after gastrointestinal surgery. However, probiotics are not yet routinely used for colorectal cancer surgery in Singapore, prompting this trial to evaluate their effects in this setting. Participants will be randomly assigned to one of three groups: no nutritional supplementation, nutritional supplementation without probiotics, or nutritional supplementation with probiotics. The nutritional supplements involved include products such as Nestle Isocal and Nestle Boost Optimum. The study is designed with quadruple masking to reduce bias and will compare the time to return of bowel function among groups. During the study, participants will be monitored for outcomes including the time to first bowel movement and time to passing gas within 14 days after surgery. Researchers will also track adverse events, infections, and length of hospital stay for up to 30 days post-surgery. Participants must be on an early recovery after surgery (ERAS) pathway and able to provide consent. The study will last from the start of treatment through 30 days after surgery, allowing detailed observation of recovery and safety.
CONDITIONS
Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive nutritional supplementation with or without probiotics around the time of colorectal cancer surgery to evaluate the time to return of bowel function.
Daily visits during hospital stay up to 14 days
Duration - 30 days
Participants are monitored for adverse events and infective complications for 30 days after surgery.
1 to 2 visits within 30 days after surgery
Total: 1 location
1
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
D
Dedrick Chan, MBBS, DPhil
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Dedrick Kok Hong Chan, Bei En Siew, Jerrald Lau...
https://pubmed.ncbi.nlm.nih.gov/39972354