Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05942404 |
| Other study ID # |
2022/785 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2023 |
| Est. completion date |
July 21, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
TC Erciyes University |
| Contact |
ayse ülgey |
| Phone |
+905378201751 |
| Email |
aulgey[@]erciyes.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cognitive impairment has been reported up to 54 % after colorectal surgeries. Mechanical
bowel cleansing means that a system called the second brain in the body, which includes a
wide variety of genetic and neuronal structures, is damaged. 100 trillion microorganisms live
in the human body. The largest contact area with the external environment in the body, is the
gastrointestinal mucosa. Microorganisms in the gut contain 100 times more genes than the
human genome. The GI mucosa contains more than 500 million neurons called the enteric nervous
system. MBP is an application that disrupts the microbiota structure and causes dehydration
and electrolyte imbalance. While the most serious indication for MBP is seen as infection and
health of anastomosis, recent studies say that this is not the case, even that the
deterioration of the microbiota content damages the mucosal barrier, predisposes to
inflammation with the removal of beneficial microorganisms and impairs wound healing.
84 patients will be included in the study, divided into two groups. In each group, blood will
be drawn to measure the levels of biomarkers determined before surgery and bowel cleansing,
on the 15th postoperative day and on the 90th day. Simultaneously, psychometric tests will be
performed to assess cognitive impairment.
Description:
In this project, the effects of pre-surgical mechanical bowel preperation on
lipopolysaccharide binding protein (LBP), brain-derived neurotrophic factor (BDNF) and Tau
protein levels and their relationship with postoperative cognitive dysfunction (PKB) are
investigated. 84 patients will be included in the study, divided into two groups. In each
group, blood will be drawn to measure the levels of biomarkers determined before surgery and
bowel cleansing, on the 15th postoperative day and on the 90th day, and will be studied with
the ELISA method. Simultaneously, psychometric tests will be performed to assess cognitive
impairment.
Postoperative cognitive impairment (PCI) is defined as deterioration and worsening of
cognitive status that occurs after surgery and lasts more than 30 days and less than 12
months. Postoperative neurological diseases are an increasing research and curiosity in the
world, and unfortunately, knowledge and experience on this subject are very limited. With the
aging of the population worldwide and the increasing number of elderly patients requiring
surgical intervention, the incidence of postoperative neurological complications is
increasing. PCD increases mortality, causes serious economic losses, psychological and social
problems in the society and the family. The most important reason in the pathophysiology of
PCD is the inflammatory response secondary to surgical intervention.
Cognitive impairment has been reported up to 54 % after colorectal surgeries. In colorectal
surgery, different from other major surgeries, bowel cleansing is performed. Mechanical bowel
cleansing means that a system called the second brain in the body, which includes a wide
variety of genetic and neuronal structures, is damaged. 100 trillion microorganisms live in
the human body. Our system, which has the largest contact area with the external environment
in the body, is the GIS mucosa. Microorganisms in the gut contain 100 times more genes than
the human genome. The GI mucosa contains more than 500 million neurons called the enteric
nervous system. Approximately 1012-13 microorganisms living in the GIS are in close
relationship with this enteric nervous system with their genetic materials.
Many studies have shown that the microbiota-gut-brain connection is effective in the
formation of neurodegenerative diseases. In animal studies, it has been shown that temporary
changes in the microbiota affect the brain chemical structure and behavior of the animal.
Recent studies show that the microbiota, which is an environmental factor, has important
effects on the brain. In intestinal surgeries, mechanical bowel preperation (MBP) was
performed, considering that the intestinal microbiota would prepare the ground for infection.
In recent years, the question of whether MBP should be done has been seriously questioned.
MBP is an application that disrupts the microbiota structure and causes dehydration and
electrolyte imbalance. While the most serious indication for MBP is seen as infection and
health of anastomosis, recent studies say that this is not the case, even that the
deterioration of the microbiota content damages the mucosal barrier, predisposes to
inflammation with the removal of beneficial microorganisms and impairs wound healing.
Prevention of PCD is very important. Because the development of PKD is an important indicator
for the first year mortality in noncardiac surgeries. Patients with PCD at discharge die
within 3 months. Patients with persistent PCD in the first 3 months postoperatively die
within the first year.
Our aim in this study is to investigate the effectiveness of certain biomarkers and whether
there is a relationship between their levels and the development of cognitive impairment in
the postoperative period in order to evaluate the clinical reflections of the microbiota
environment that has been intervened by performing MBT in colorectal surgeries that have
never been investigated.
