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

Not Applicable

Recruiting

• Conditions: Ileus Postoperative; Flatus; Colorectal Cancer; Diet, Healthy
• Interventions: Dietary Supplement: Nestle Isocal; Dietary Supplement: Nestle Boost Optimum

• Registration Number: NCT06456229
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-07-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Nestle Isocal	Control arm with nutritional supplementation but without probiotics
Arm 3	Nestle Boost Optimum	Nutritional supplementation with probiotics

Primary Outcome Measures

Name	Time	Method
Time to bowel movement	0 - 14 days	This records the number of days from the day of surgery before the first bowel movement was experienced by the patient.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore