A Study on a New Indicator for Assessing the Difficulty of Colonoscopy Insertion and Its Related Factors

NCT07228715 | Active Not Recruiting DMC

• 1 other identifier: 2024467
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

the Difficulty of Colonoscopy Insertion

Outcome Measures

Primary Outcomes (1)

• Time Required for Insertion to the Cecum (Cecal Intubation Time, CIT)

  From enrollment to the end of treatment at 1 weeks

Study Arms (2)

Junior Doctor Group

Senior Doctor Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo colonoscopy at the Second Hospital of Jilin University

You may qualify if:

• Patients who voluntarily undergo colonoscopy

You may not qualify if:

• patients who failed to complete the colonoscopy

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

Department of Gastroenterology and Digestive Endoscopy Center, The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (2)

• 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.

  PMID: 39138684 RESULT

• 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.

  PMID: 19136102 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)