Colorectal Cancer Clinical Trial
Official title:
Prognostic Significance of Bacterial Translocation Markers as Predictors of Infectious and Inflammatory Complications in Acute Mechanical Bowel Obstruction
Verified date | October 2023 |
Source | Karaganda Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Despite modern approaches to the diagnosis and treatment of acute bowel obstruction (ABO), postoperative mortality ranges from 5 to 32%, and complications occur up 23% of cases. One of the formidable infectious and inflammatory complications of ABO is sepsis. The main component of the development of sepsis in ABO is bacterial translocation (BT). BT is the migration of intestinal bacteria or their products through the intestinal mucosa into the mesenteric lymph nodes and further into normally sterile tissues and organs. Today there are several methods for detecting BT: 1. direct method - the detection of 16s rRNA (ribosomal ribonucleic acid) in mesenteric lymph nodes (MLN); 2. indirect method - the detection of serum lipopolysaccharide-binding protein (LBP) and presepsin (Soluble CD14 subtype or sCD14-ST). The aim of this study is to determine the diagnostic and prognostic significance of bacterial translocation as a predictor of the complications development in patients with malignant and benign acute bowel obstruction by assessing the relationship of biomarkers in the systemic circulation (LBP, sCD14-ST) with the detection of microorganism genes (16s rRNA) in mesenteric lymph nodes.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with malignant acute bowel obstruction, - patients with benign acute bowel obstruction, - colorectal cancer patients without acute bowel obstruction (planned operations). Exclusion Criteria: - age less than 18, - pregnancy, - patients with paralytic acute bowel obstruction, - patients with HIV infection, liver cirrhosis, - patient with an infectious process due to another pathology. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | NJSC Karaganda Medical University | Karaganda |
Lead Sponsor | Collaborator |
---|---|
Karaganda Medical University | Ministry of Education and Science, Republic of Kazakhstan |
Kazakhstan,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of Participants with Post-operative infectious and inflammatory complications | ?ny infectious and inflammatory complications in post-operative period (wound suppuration, anastomotic leak, ?bdominal abscesses, peritonitis, sepsis, etc.) | day 3, day 7, day 10 | |
Secondary | LBP level in serum blood | LBP levels will be compared between groups/ subgroups and in each group/subgroup in dynamic. | 1 hour before surgery, 24 hours after surgery, 72 hours after surgery | |
Secondary | sCD14-ST level in serum blood | sCD14-ST levels will be compared between groups/ subgroups and in each group/subgroup in dynamic. | 1 hour before surgery, 24 hours after surgery, 72 hours after surgery | |
Secondary | 16s rRNA in mesenteric lymph nodes | Presence or absence of 16s rRNA in mesenteric lymph nodes will be compared between groups/subgroups. | Once (MLN sampling in sterile conditions during surgery) |
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