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

NCT ID: NCT07228715

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Junior Doctor Group

No interventions assigned to this group

Senior Doctor Group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients who voluntarily undergo colonoscopy

Exclusion Criteria

• patients who failed to complete the colonoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 39138684 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19136102 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024467

Identifier Type: -

Identifier Source: org_study_id