Colorectal Cancer
Conditions
Keywords
Probiotics, Lactobacillus casei Shirota, Lactobacillus acidophilus, Colorectal cancer, Surgical outcomes
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALLactobacillus casei Shirota
Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
BIOLOGICALLactobacillus acidophilus
Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Sponsors
Dharmais National Cancer Center Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1\. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital
Exclusion criteria
1. The patient or patient's family refused to be included in the study 2. Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure 3. Patients with a history of regular probiotics, or steroids, or antibiotics consumption 4. Patients with anatomical disorders of the gastrointestinal system 5. Patients with immunocompromised conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Function | Second day of treatment in the ICU | 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) |
| Sepsis Incidence | second, fourth, and sixth days of treatment | Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention |
| C-reactive protein (CRP) | Baseline, four hours before surgery and three days after surgery | 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 |
| Interleukin 6 (IL-6) | Baseline and three days after surgery | 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. |
| Length of stay | Up to 16 days (documented maximum length of stay) | The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient |
Countries
Indonesia
Outcome results
None listed