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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Diet, Healthy; Ileus Postoperative; Flatus
• Intervention / Treatment: Dietary supplement: Nestle Isocal; Dietary supplement: Nestle Boost Optimum

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dedrick Chan, MBBS, DPhil; Phone Number: 67795555; Email: surckhd@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Principal Investigator: Dedrick Chan, MBBS, DPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; Control arm with no nutritional supplementation
Active Comparator: Arm 2; Control arm with nutritional supplementation but without probiotics	Dietary supplement: Nestle Isocal; Nestle Isocal
Experimental: Arm 3; Nutritional supplementation with probiotics	Dietary supplement: Nestle Boost Optimum; Nestle Boost Optimum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to bowel movement	This records the number of days from the day of surgery before the first bowel movement was experienced by the patient.	0 - 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to flatus	This records the number of days from the day of surgery before the first flatus was experienced by the patient.	0 - 14 days
Adverse events	Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications	From commencement of the intervention to 30 days after surgery
Infective complications	Any infective complications which may occur in the postoperative period.	From date of surgery to 30 days after surgery
Length of hospital stay	This records the number of days following surgery before the patient is discharged.	0 - 14 days

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; complications; probiotics; colorectal surgery; length of stay; nutritional supplementation; time to bowel movement; time to flatus
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2024/00180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No