Actively Recruiting

Phase Not Applicable
Age: 21Years - 99Years
All Genders
ID06456229

Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)

Led by National University Hospital, Singapore · Updated on 2024-06-13

162

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery

Who Can Participate

Age: 21Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing elective colorectal cancer surgery with planned oncologic resection
  • Aged between 21 and 99 years at the time of consent
  • Willing to consider oral nutritional supplementation
  • On an early recovery after surgery (ERAS) pathway
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Known contraindications to probiotic use
  • Undergoing emergency surgery
  • Currently taking any other form of probiotics
  • Taking oral antibiotics within 7 days before starting the study
  • Vulnerable patients, including pregnant individuals, inmates, or those unable to provide informed consent due to cognitive impairment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

National University Hospital

Singapore, Singapore, 119074

Actively Recruiting

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Research Team

D

Dedrick Chan, MBBS, DPhil

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

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/39972354