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

NCT05942404 | Completed

• 1 other identifier: 2022/785
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Bowel Preparation; POCD - Postoperative Cognitive Dysfunction

Keywords

POCD; TAU PROTEİN; BDNF; LBP

Outcome Measures

Primary Outcomes (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

  3

Study Arms (2)

Group of no bowel preparation

NO INTERVENTION

none mechanical bowel preparation

Group of bowel preparation

ACTIVE COMPARATOR

mechanical bowel preparation

Procedure: mechanical bowel preparation

Interventions

mechanical bowel preparation PROCEDURE

mechanical bowel preparation before surgery

Group of bowel preparation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR DR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 12, 2023
• Study Start: October 22, 2023
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

TU (1)