Health TrialsbyHealthPanel

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

ConditionsColorectal CancerIleus PostoperativeFlatusDiet, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nestle Isocal

    Dietary supplement

    Nestle Isocal

  • Nestle Boost Optimum

    Dietary supplement

    Nestle Boost Optimum

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: Arm 1No intervention 0 interventions
Group B: Arm 2Active comparator 1 intervention
Group C: Arm 3Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
0 - 14 days

Secondary outcomes

1

Time to flatus

This records the number of days from the day of surgery before the first flatus was experienced by the patient.

Time frame
0 - 14 days
2

Adverse events

Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications

Time frame
From commencement of the intervention to 30 days after surgery
3

Infective complications

Any infective complications which may occur in the postoperative period.

Time frame
From date of surgery to 30 days after surgery
4

Length of hospital stay

This records the number of days following surgery before the patient is discharged.

Time frame
0 - 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

Source ClinicalTrials.gov
Apply now