Colorectal DisordersNCT06531226
Difficult Colonoscopy and Personality Traits
An observational study of Colorectal Disorders, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
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. CIT greater than 10 minutes is considered a difficult colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Fill in personality questionnaires
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 1 May 2025
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: The study population consisted of patients who underwent colonoscopy at our hospital. They should meet the aforementioned inclusion criteria did not meet the exclusion criteria. Due to the widespread application of colonoscopy, the above patients may include patients suspected of having various organic or non-organic basic intestinal diseases, as well as health check-up patients.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Feixue Chen, +8618560086108, chenfeixue@email.sdu.edu.cn
About this study
Official title: Personality Traits and Colonoscopy Insertion Time: Applying Machine Learning to Predict the Colonoscopy Time and Difficult Colonoscopy
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. CIT greater than 10 minutes is considered a difficult colonoscopy. Studies have identified factors that influence CIT, including age, gender, body mass index (BMI), waist circumference, bowel preparation, prior abdominal surgery, etc. 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). There is a lack of research on the association between personality traits and colonoscopy insertion time, and the purpose of this study is to investigate whether personality, BMI, age, gender, anxiety and depression index, metabolic diseases, and abdominal pelvic surgery history lead to prolonged colonoscopy insertion time and difficult colonoscopy, and to identify significant variables as predictors by using machine learning methods to build a clinical diagnostic model to predict colonoscopy insertion time and identify difficult colonoscopy patients.
Read the 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.
- Conditions
- Colorectal Disorders
- Being tested
- Fill in personality questionnaires
- Keywords
- machine learning, difficult colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill in personality questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High neuroticism score group | The neuroticism score was higher than the average score identified by the norm Receives: Other: Fill in personality questionnaires | |
| Low neuroticism score group | The neuroticism score was lower than the average score identified by the norm Receives: Other: Fill in personality questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of difficult colonoscopy
CIT(cecum insertion time) was applied to evaluate difficult colonoscopy, a prolonged CIT (>10min) was considered difficult colonoscopy
Measured: The evaluation of difficult colonoscopies was performed immediately after the patient completed the questionnaire at the next colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531226
- Sponsor's protocol ID
- KYLL-202406-030
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25651787Center 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.
PubMed 19897840Brenner 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.
PubMed 22826281Jaruvongvanich 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.
PubMed 29520457Terracciano 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.
PubMed 19002272Zhang 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.
PubMed 33884926
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Traits and Colonoscopy Insertion Time: Applying Machine Learning to Predict the Colonoscopy Time and Difficult Colonoscopy
- ClinicalTrials.gov ID
- NCT06531226
- Acronym / sponsor ID
- KYLL-202406-030
- Conditions
- Colorectal Disorders
- Keywords
- machine learning, difficult colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. CIT greater than 10 minutes is considered a difficult colonoscopy. Studies have identified factors that influence CIT, including age, gender, body mass index (BMI), waist circumference, bowel preparation, prior abdominal surgery, etc. 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). There is a lack of research on the association between personality traits and colonoscopy insertion time, and the purpose of this study is to investigate whether personality, BMI, age, gender, anxiety and depression index, metabolic diseases, and abdominal pelvic surgery history lead to prolonged colonoscopy insertion time and difficult colonoscopy, and to identify significant variables as predictors by using machine learning methods to build a clinical diagnostic model to predict colonoscopy insertion time and identify difficult colonoscopy patients.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High neuroticism score group | – | Other: Fill in personality questionnairesThe neuroticism score was higher than the average score identified by the norm |
| Low neuroticism score group | – | Other: Fill in personality questionnairesThe neuroticism score was lower than the average score identified by the norm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study population consisted of patients who underwent colonoscopy at our hospital. They should meet the aforementioned inclusion criteria did not meet the exclusion criteria. Due to the widespread application of colonoscopy, the above patients may include patients suspected of having various organic or non-organic basic intestinal diseases, as well as health check-up patients.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fill in personality questionnairesFor 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. | Other | High neuroticism score group, Low neuroticism score group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 25651787Torre 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.
- Background: PubMed 19897840Center 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.
- Background: PubMed 22826281Brenner 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.
- Background: PubMed 29520457Jaruvongvanich 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.
- Background: PubMed 19002272Terracciano 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.
- Background: PubMed 33884926Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders, run by Qilu Hospital of Shandong University at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feixue Chen, Doctor of Medicine (18560086108, chenfeixue@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06531226, which also lists 6 linked publications.
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 31 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.