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Investigation of the Effect of Preoperative Bowel Cleansing on Postoperative Cognitive Impairment

Primary Purpose

POCD - Postoperative Cognitive Dysfunction, Mechanical Bowel Preparation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mechanical bowel preparation
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for POCD - Postoperative Cognitive Dysfunction focused on measuring POCD, TAU PROTEİN, BDNF, LBP

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients who agreed to participate in the study Patients undergoing elective colorectal surgery Patients who can read and write Patients whose hearing and sight are suitable for communication Patients whose general sociocultural status is sufficient to perform psychometric tests. Exclusion Criteria: Patients with inflammatory bowel Patients with cerebrovascular disease Patients who require emergency surgery Patients who have had repetitive surgeries Patients with neurodegenerative disease Patients with severe and moderate dementia (MoCA test score 21 and below) Patients with a mini mental test below 24 Patients with severe hearing and vision impairment Patients using antibiotics and probiotics Patients who take long-term steroid therapy (7 days or more) Patients receiving immunosuppressive therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Group of no bowel preparation

    Group of bowel preparation

    Arm Description

    none mechanical bowel preparation

    mechanical bowel preparation

    Outcomes

    Primary Outcome Measures

    the incidence of postoperative cognitive disfunction
    1st day before the operation, 15th day and 90th day after the operation the psychometric tests will be performed to evaluate POCD relevant biomarkers will also be measured

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2023
    Last Updated
    July 4, 2023
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05942404
    Brief Title
    Investigation of the Effect of Preoperative Bowel Cleansing on Postoperative Cognitive Impairment
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 22, 2023 (Anticipated)
    Primary Completion Date
    July 21, 2024 (Anticipated)
    Study Completion Date
    July 21, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    POCD - Postoperative Cognitive Dysfunction, Mechanical Bowel Preparation
    Keywords
    POCD, TAU PROTEİN, BDNF, LBP

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group of no bowel preparation
    Arm Type
    No Intervention
    Arm Description
    none mechanical bowel preparation
    Arm Title
    Group of bowel preparation
    Arm Type
    Active Comparator
    Arm Description
    mechanical bowel preparation
    Intervention Type
    Procedure
    Intervention Name(s)
    mechanical bowel preparation
    Intervention Description
    mechanical bowel preparation before surgery
    Primary Outcome Measure Information:
    Title
    the incidence of postoperative cognitive disfunction
    Description
    1st day before the operation, 15th day and 90th day after the operation the psychometric tests will be performed to evaluate POCD relevant biomarkers will also be measured
    Time Frame
    3

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who agreed to participate in the study Patients undergoing elective colorectal surgery Patients who can read and write Patients whose hearing and sight are suitable for communication Patients whose general sociocultural status is sufficient to perform psychometric tests. Exclusion Criteria: Patients with inflammatory bowel Patients with cerebrovascular disease Patients who require emergency surgery Patients who have had repetitive surgeries Patients with neurodegenerative disease Patients with severe and moderate dementia (MoCA test score 21 and below) Patients with a mini mental test below 24 Patients with severe hearing and vision impairment Patients using antibiotics and probiotics Patients who take long-term steroid therapy (7 days or more) Patients receiving immunosuppressive therapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ayşe ülgey
    Phone
    +905378201751
    Email
    aulgey@erciyes.edu.tr

    12. IPD Sharing Statement

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    Investigation of the Effect of Preoperative Bowel Cleansing on Postoperative Cognitive Impairment

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