Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Psychiatric evaluation

• Registration Number: NCT02970513
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.

Detailed Description

Colonic colonization by pathogenic Escherichia coli was determined when patients were operated on for colorectal cancer.

Several years later, the investigator investigate past and actual psychiatric disorder using the Mini International Neuropsychiatric Interview (MINI). Actual depression and anxiety scores are evaluated with Hamilton scales and personality traits are investigated using Personality Inventory for DSM-5 (PID-5).

Anxiety and depression scores, psychiatric diagnoses (MINI) and personality traits were compared in patients according to Escherichia coli presence/absence.

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-22
• Study Start: 2017-03-27
• Primary Completion: 2017-09-27
• Study Completion: 2017-10-27
• Status Verified: 2019-02
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• patients operated on for colorectal cancer in the digestive surgery department of Clermont-Ferrand hospital
• patients older than 18 years,
• patients whose Escherichia coli colonization was analyzed after surgery
• patients which are always followed by the digestive surgery department.

Exclusion Criteria

• Patients with dementia will not be included, according to the MMSE score:
• 22 if no grade
• 23 if study certificate or CAP or college without patent
• 25 if patent or school without the tray
• 26 or more when bin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients operated on for colorectal cancer	Psychiatric evaluation	-

Primary Outcome Measures

Name	Time	Method
Hamilton anxiety and depression score comparison	at day 1	Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli

Secondary Outcome Measures

Name	Time	Method
Psychiatric prevalence comparison	at day 1	prevalence of each past and actual psychiatric disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI: major depression, dysthymia, suicidal risk, hypomania, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, dependence and abuse of alcohol, tobacco- dependence, psychotic disorders and generalized anxiety disorder) will be compared in patients according to colonic colonization by Escherichia coli.
personality traits comparison	at day 1	personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France