Sigmoid Colon Cancer
Conditions
Brief summary
The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.
Detailed description
The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.
Interventions
DRUGMechnicov probiotics
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
DRUGPlacebo
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
Sponsors
Kye Bong-Hyeon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Intervention model description
This study has been designed for randomized, double Blinded, placebo clinical trial.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult male or female aged 20 to over 75 years old 2. As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection 3. Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.
Exclusion criteria
1. Those who have metastatic colorectal cancer screening 2. Those who have urinary incontinence or fecal incontinence 3. Those who received preoperative chemotherapy or radiotherapy 4. Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy) 5. Those who have neurologist or psychologically important psychiatric history or current disease 6. Those who have alcohol addiction, substance abuse 7. Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease) 8. Those who have uncontrolled hypertension, diabetes patients 9. Those who have creatinine with more than twice from normal upper limit in site 10. Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site 11. Those who have probiotics, antibiotics, continually within the last one week 12. Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice 13. Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial 14. under the investigator's judgment, those who is not qualified to participate this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior resection syndrome improvement change | 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery | 3 times performed through questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clavien-Dindo Classification | 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery | Assessment through Clavien-Dindo Classification |
| Markers related Inflammation | 1 week before surgery, 4 weeks after surgery | WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio |
| Bowel examination | 4 weeks after surgery, 5 weeks after surgery | 2 times performed through questionnaire |
| NSI(Nutritional Screening Index) | 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery | PG-SGA: Patient-Generated Subjective Global Assessment |
| NGS, SCFA | 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery | NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid) |
| Other biomarkers | 1 week before surgery, 4 weeks after surgery | Zonulin, other Cytokines |
| Quality of Life of Cancer Patients(EORTC QLQ-C30) | 1 week before surgery, 4 weeks after surgery | 2 times performed through questionnaire |
Countries
South Korea
Outcome results
None listed