This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Researchers will compare probiotic to see if Lactobacillus casei Shirota improves gastrointestinal function, sepsis incidence, C-reactive protein (CRP), interleukin 6 (IL-6), and length of stay better than Lactobacillus acidophilus. Participants will take probiotics three times daily for three days before surgery.
The research design was a two-group unblinded, randomized clinical trial in 90 adult patients undergoing colorectal cancer surgery who are treated in the ICU, HCU and wards of Dharmais Cancer Hospital. Subjects who meet the criteria are divided into 2 (two) groups: the group given Lactobacillus casei Shirota and Lactobacillus acidophilus probiotics. Assessment of gastrointestinal function using the I-FEED score for early feeding was carried out on the second day after surgery. Sepsis diagnosis used the NEWS2 scoring assessed on the second, fourth, and sixth days of treatment. CRP levels were measured three times, namely during perioperative visit before surgery, four hours before surgery and three days after surgery. IL-6 levels were measured twice, namely perioperative visit before surgery and three days after surgery. Length of stay was calculated from after surgery until the patient was discharged.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
90
Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia
Gastrointestinal Function
Assessed using I-FEED score which measures postoperative gastrointestinal function that contains five elements (intake, response to nausea treatment, emesis, examination, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)
Time frame: Second day of treatment in the ICU
Sepsis Incidence
Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention
Time frame: second, fourth, and sixth days of treatment
C-reactive protein (CRP)
CRP is a protein synthesized in the liver and will increase in response to inflammation. Baseline CRP data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption
Time frame: Baseline, four hours before surgery and three days after surgery
Interleukin 6 (IL-6)
IL-6 is a soluble mediator that has several functions in the immune response. IL-6 is produced in response to infection or tissue trauma. Baseline IL-6 data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption.
Time frame: Baseline and three days after surgery
Length of stay
The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient
Time frame: Up to 16 days (documented maximum length of stay)
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