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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Ileus Postoperative Flatus Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Control arm with no nutritional supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2

Control arm with nutritional supplementation but without probiotics

Group Type ACTIVE_COMPARATOR

Nestle Isocal

Intervention Type DIETARY_SUPPLEMENT

Nestle Isocal

Arm 3

Nutritional supplementation with probiotics

Group Type EXPERIMENTAL

Nestle Boost Optimum

Intervention Type DIETARY_SUPPLEMENT

Nestle Boost Optimum

Interventions

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Nestle Isocal

Intervention Type DIETARY_SUPPLEMENT

Nestle Boost Optimum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No