N/A
N=150
Bacterial Translocation Markers as Predictors of Infectious and Inflammatory Complications in Acute Bowel Obstruction
Intestinal Obstruction · Colorectal Cancer · Post-Op Complication · Systemic Inflammatory Response Syndrome · Colon Tumor
Bottom Line
View on ClinicalTrials.gov: NCT05229822 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in Number of Participants With Post-operative Infectious and Inflammatory Complications — 43; 47; 25; 17 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- LBP (Diagnostic_test); sCD14-ST (Diagnostic_test); 16s rRNA (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karaganda Medical University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Participants With Post-operative Infectious and Inflammatory Complications |
43; 47; 25; 17; 13; 5 | — |
| SECONDARY LBP Level in Serum Blood |
1164.4; 971.4; 1015.1; 890.9; 897.9; 1180.0 | — |
| SECONDARY sCD14-ST Level in Serum Blood |
571.7; 245.7; 485.2; 527.8; 227.6; 386.5 | — |
| SECONDARY 16s rRNA in Mesenteric Lymph Nodes |
15; 16; 0; 45; 44; 5 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05229822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.