- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531226
Difficult Colonoscopy and Personality Traits
Personality Traits and Colonoscopy Insertion Time: Applying Machine Learning to Predict the Colonoscopy Time and Difficult Colonoscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cecal intubation time (CIT) refers to the time required for the tip of the colonoscope to reach the cecum from passing through the anus. A prolonged CIT is considered a marker of difficulty in colonoscopy. A CIT greater than 10 minutes is considered a difficult colonoscopy. A longer CIT is associated with a lower adenoma detection rate, as it is an indicator of an ineffective colonoscopy, while a shorter CIT will provide the endoscopist with more time for colonoscope retrieval, increasing the likelihood of adenoma detection.
Research has identified factors that influence CIT, including age, gender, body mass index (BMI), waist circumference, bowel preparation, and prior abdominal surgery history.
Personality traits have been found to be associated with the onset of many diseases, such as hypertension and A-type personality, depression, and neurotic personality. According to the Big Five personality theory, personality can be decomposed into five dimensions: openness (O), conscientiousness (C), extraversion (E), agreeableness (A), and neuroticism (N). The Big Five personality theory is a commonly used personality typology in scientific research and has been confirmed in numerous studies. The Big Five Personality Inventory (BFI) is a tool for detecting the classification of the Big Five personality traits. The Chinese version of the Big Five Personality Inventory and norms were jointly revised by Professor Li Jian from the Department of Psychology, Beijing Normal University, and the scale norms were constructed to include people of different age groups. The scale has shown excellent reliability and validity.
The discovery of the brain-gut axis suggests that neural activity can affect the intestinal activity in various ways directly or indirectly, thereby affecting the difficulty of colonoscopy, but there is still a lack of research on the relationship between personality types and difficult colonoscopy, and the specific correlation has not been clarified. What's more important is that previous studies often used ordinary least squares regression (OLS regression) or logistic regression The purpose of this study is to investigate whether personality, BMI, age, gender, anxiety and depression index, metabolic diseases, and history of abdominal and pelvic surgery are associated with prolonged colonoscopy insertion time and difficult colonoscopy, and to construct a clinical diagnostic model by using machine learning methods to predict colonoscopy insertion time and identify difficult colonoscopy patients based on significant variables.
The basic research framework is designed as follows:
Invite patients scheduled for colonoscopy to fill out the "Personality Tendency and Colonoscopy Survey Questionnaire" before colonoscopy.
Record the completion of colonoscopy and CIT for patients during colonoscopy and record the preparation of the colon and the presence of serious organic diseases.
Collect other patient information, including age, gender, and history of major diseases.
All patients included in the study should meet the inclusion criteria and not meet the exclusion criteria.
Organize the data and divide the patients into two groups based on whether their CIT time is greater than 10 minutes.
Use t-tests and chi-square analysis to determine whether each factor is related to difficult colonoscopy, with a significance threshold of P<0.05.
Include significant variables in logistic regression for initial analysis and calculate OR.
Use LASSO regression for sparse selection and include non-zero features in the machine learning model construction.
Divide the data into training set and test set and construct random forest models, artificial neural network models, and support vector machine models, etc. Through receiver operating curve (ROC), precision, accuracy, recall rates, etc., the model's error can be evaluated, and the model's generalization ability can be compared.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Feixue Chen, Doctor of Medicine
- Phone Number: 18560086108
- Email: chenfeixue@email.sdu.edu.cn
Study Contact Backup
- Name: yf wu, Master of Medicine
- Phone Number: 13563419287
- Email: 707932001@qq.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250000
- Qilu Hospital of Shandong University
-
Contact:
- Feixue Chen
- Phone Number: +8618560086108
- Email: chenfeixue@email.sdu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Colonoscopy patients tested 18 to 60 years old, men and women there is no limit
- Insert the cecum complete colonoscopy examination (successfully)
- Agree and complete personality questionnaire and anxiety depression
Exclusion Criteria:
- Maternal/pregnancy/lactation
- Has a history of colorectal resection of colorectal surgery
- Have organic diseases such as severe ulcerative colitis or intestinal tumors
- Inadequate bowel preparation (bowel with feces and less than 90% visible area of mucosa)
- Confirmed with the immune system (SLE), nervous system (Alzheimer's disease), mental system (such as schizophrenia, depression), urinary system disease (CKD), and other digestive system disease
- Unable or unwilling to sign informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High neuroticism score group
The neuroticism score was higher than the average score identified by the norm
|
For patients who need to undergo colonoscopy, we invite them to fill out a personality survey questionnaire after obtaining their informed consent.
The questionnaire contains 60 survey questions, which cover the five dimensions of the Big Five personality traits.
Each question has five options, corresponding to the five states of very disagree to very agree.
The questionnaire was developed based on the Chinese population and has four norms applicable to different age groups to ensure the reliability of the questionnaire.
|
|
Low neuroticism score group
The neuroticism score was lower than the average score identified by the norm
|
For patients who need to undergo colonoscopy, we invite them to fill out a personality survey questionnaire after obtaining their informed consent.
The questionnaire contains 60 survey questions, which cover the five dimensions of the Big Five personality traits.
Each question has five options, corresponding to the five states of very disagree to very agree.
The questionnaire was developed based on the Chinese population and has four norms applicable to different age groups to ensure the reliability of the questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The occurrence of difficult colonoscopy
Time Frame: The evaluation of difficult colonoscopies was performed immediately after the patient completed the questionnaire at the next colonoscopy
|
CIT(cecum insertion time) was applied to evaluate difficult colonoscopy, a prolonged CIT (>10min) was considered difficult colonoscopy
|
The evaluation of difficult colonoscopies was performed immediately after the patient completed the questionnaire at the next colonoscopy
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
- Center MM, Jemal A, Smith RA, Ward E. Worldwide variations in colorectal cancer. CA Cancer J Clin. 2009 Nov-Dec;59(6):366-78. doi: 10.3322/caac.20038.
- Jaruvongvanich V, Sempokuya T, Laoveeravat P, Ungprasert P. Risk factors associated with longer cecal intubation time: a systematic review and meta-analysis. Int J Colorectal Dis. 2018 Apr;33(4):359-365. doi: 10.1007/s00384-018-3014-x. Epub 2018 Mar 9.
- Terracciano A. The Italian version of the NEO PI-R: Conceptual and empirical support for the use of targeted rotation. Pers Individ Dif. 2003;35(8):1859-1872. doi: 10.1016/S0191-8869(03)00035-7.
- Zhang B, Li YM, Li J, Luo J, Ye Y, Yin L, Chen Z, Soto CJ, John OP. The Big Five Inventory-2 in China: A Comprehensive Psychometric Evaluation in Four Diverse Samples. Assessment. 2022 Sep;29(6):1262-1284. doi: 10.1177/10731911211008245. Epub 2021 Apr 22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KYLL-202406-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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