AzTrials
AzTrials

POCD - Postoperative Cognitive DysfunctionNCT05942404

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

A study testing mechanical bowel preparation in people with POCD - Postoperative Cognitive Dysfunction and Mechanical Bowel Preparation, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 80 years, men only
What is being tested?
mechanical bowel preparation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Oct 2023to 21 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University

    Melikgazi, Kayseri

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
mechanical bowel preparation
Keywords
POCD, TAU PROTEİN, BDNF, LBP
Medical subject headings
Postoperative Cognitive Complications, Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mechanical bowel preparationProcedure or surgery

    mechanical bowel preparation before surgery

Study groups in NCT05942404
Study groupRoleWhat they receive
Group of no bowel preparationNo interventionnone mechanical bowel preparation
Group of bowel preparationActive comparatormechanical bowel preparation
Receives: Procedure: mechanical bowel preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start22 Oct 2023
  3. Primary completion21 Jul 2024
  4. Study completion21 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05942404
Sponsor's protocol ID
2022/785
Status last verified
Mar 2026
First submitted
14 Jun 2023
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mechanical bowel preparation in people with POCD - Postoperative Cognitive Dysfunction and Mechanical Bowel Preparation, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of postoperative cognitive disfunction (time frame: 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in