NCT06531226

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

machine learningdifficult colonoscopy

Outcome Measures

Primary Outcomes (1)

  • The occurrence of difficult 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

Study Arms (2)

High neuroticism score group

The neuroticism score was higher than the average score identified by the norm

Other: Fill in personality questionnaires

Low neuroticism score group

The neuroticism score was lower than the average score identified by the norm

Other: Fill in personality questionnaires

Interventions

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.

High neuroticism score groupLow neuroticism score group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Related Publications (6)

  • 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.

    PMID: 25651787BACKGROUND
  • 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.

    PMID: 19897840BACKGROUND
  • 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.

    PMID: 22826281BACKGROUND
  • 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.

    PMID: 29520457BACKGROUND
  • 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.

    PMID: 19002272BACKGROUND
  • 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.

    PMID: 33884926BACKGROUND

Central Study Contacts

Feixue Chen, Doctor of Medicine

CONTACT

yf wu, Master of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

July 30, 2024

Primary Completion

December 30, 2024

Study Completion

May 1, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations