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

NCT06456229 | Recruiting

• 1 other identifier: 2024/00180
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Ileus Postoperative; Flatus; Diet, Healthy

Keywords

colorectal cancer; colorectal surgery; nutritional supplementation; probiotics; time to bowel movement; time to flatus; length of stay; complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to flatus

  0 - 14 days

• Adverse events

  From commencement of the intervention to 30 days after surgery

• Infective complications

  From date of surgery to 30 days after surgery

• Length of hospital stay

  0 - 14 days

Study Arms (3)

Arm 1

NO INTERVENTION

Control arm with no nutritional supplementation

Arm 2

ACTIVE COMPARATOR

Control arm with nutritional supplementation but without probiotics

Dietary Supplement: Nestle Isocal

Arm 3

EXPERIMENTAL

Nutritional supplementation with probiotics

Dietary Supplement: Nestle Boost Optimum

Interventions

Nestle Isocal DIETARY_SUPPLEMENT

Nestle Isocal

Arm 2

Nestle Boost Optimum DIETARY_SUPPLEMENT

Nestle Boost Optimum

Arm 3

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective colorectal cancer surgery in which an oncologic resection is planned
• age 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

You may not qualify if:

• patients with known contraindications to probiotic use
• patients undergoing emergency surgery
• taking any other form of probiotics
• taking oral antibiotics within 7 days of commencement of study
• vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

• Chan DKH, Siew BE, Lau J, Koh J, Lee MX, Ang C, Pang NQ, Tan KK. Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial. Trials. 2025 Feb 19;26(1):60. doi: 10.1186/s13063-025-08773-2.

  PMID: 39972354 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Flatulence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dedrick Chan, MBBS, DPhil

CONTACT

67795555; surckhd@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)