To hear about similar clinical trials, please enter your email below
Trial Title:
Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery
NCT ID:
NCT06456229
Condition:
Colorectal Cancer
Ileus Postoperative
Flatus
Diet, Healthy
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
colorectal surgery
nutritional supplementation
probiotics
time to bowel movement
time to flatus
length of stay
complications
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Nestle Isocal
Description:
Nestle Isocal
Arm group label:
Arm 2
Intervention type:
Dietary Supplement
Intervention name:
Nestle Boost Optimum
Description:
Nestle Boost Optimum
Arm group label:
Arm 3
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Investigator:
Last name:
Dedrick Chan, MBBS, DPhil
Email:
Principal Investigator
Start date:
July 1, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06456229
