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

Colorectal Cancer Clinical Trial

— PICCS-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456229
• Other study ID #: 2024/00180
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: National University Hospital, Singapore
• Contact: Dedrick Chan, MBBS, DPhil
• Phone: 67795555
• Email: surckhd[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Diet, Healthy
• Flatus

Intervention

Dietary Supplement:
• Nestle Isocal
Nestle Isocal
• Nestle Boost Optimum
Nestle Boost Optimum

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Infective complications	Any infective complications which may occur in the postoperative period.	From date of surgery to 30 days after surgery
Secondary	Length of hospital stay	This records the number of days following surgery before the patient is discharged.	0 - 14 days