- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228715
A Study on a New Indicator for Assessing the Difficulty of Colonoscopy Insertion and Its Related Factors
This study will include adult patients undergoing painless colonoscopy at our hospital. The time required for endoscope insertion to reach the cecum (Cecal Intubation Time, CIT) by physicians of different experience levels will be recorded. CIT roughly reflects the difficulty of colonoscope insertion, which holds important clinical significance and is associated with factors such as abdominal pain, bloating, and the degree of intestinal adhesion. However, due to confounding factors such as operator experience and equipment variability, the objectivity of CIT as an indicator of insertion difficulty is reduced.
In this study, all patients' CIT data will be standardized using three different methods: Z-score standardization, median standardization, and quantile normalization. The goal is to determine which standardized form of CIT can more objectively reflect insertion difficulty and its correlation with important clinical indicators.
The purpose of this study is to establish a novel indicator that can objectively assess colonoscope insertion difficulty across different operating environments, thereby providing a scientific basis for the development of clinical treatment strategies.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Jilin
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Changchun, Jilin, China, 130000
- Department of Gastroenterology and Digestive Endoscopy Center, The Second Hospital of Jilin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who voluntarily undergo colonoscopy
Exclusion Criteria:
- patients who failed to complete the colonoscopy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Junior Doctor Group
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Senior Doctor Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time Required for Insertion to the Cecum (Cecal Intubation Time, CIT)
Time Frame: From enrollment to the end of treatment at 1 weeks
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From enrollment to the end of treatment at 1 weeks
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Collaborators and Investigators
Publications and helpful links
General Publications
- Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
- Dincer B, Omeroglu S, Guven O, Akgun IE, Celayir MF, Gurbulak EK, Yazici P, Koksal HM, Demir U. Factors predict prolonged colonoscopy before the procedure: prospective registry study. Surg Endosc. 2024 Oct;38(10):5704-5711. doi: 10.1007/s00464-024-11075-4. Epub 2024 Aug 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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