Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05942404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-12
First Post:
2023-06-14
Brief Title:
Investigation of the Effect of Preoperative Bowel Cleansing on Postoperative Cognitive Impairment
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
Investigation of the Effect of Preoperative Bowel Cleansing on Lipopolysaccharide Binding Protein Brain-Derived Neurotrophic Factor and Tau Protein Levels and Their Relationship With Postoperative Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None