the Difficulty of Colonoscopy InsertionNCT07228715
A Study on a New Indicator for Assessing the Difficulty of Colonoscopy Insertion and Its Related Factors
An observational study of the Difficulty of Colonoscopy Insertion, run by Second Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Difficulty of Colonoscopy Insertion
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Apr 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo colonoscopy at the Second Hospital of Jilin University
Who may be able to join
- Patients who voluntarily undergo colonoscopy
Who cannot join
- patients who failed to complete the colonoscopy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology and Digestive Endoscopy Center, The Second Hospital of Jilin University
Changchun, Jilin, 130000
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Junior Doctor Group | Not described | |
| Senior Doctor Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Required for Insertion to the Cecum (Cecal Intubation Time, CIT)
Measured: From enrollment to the end of treatment at 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for the Difficulty of Colonoscopy InsertionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228715
- Sponsor's protocol ID
- 2024467
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect patients' privacy
Publications
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.
PubMed 39138684Lai 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.
PubMed 19136102Zhang Y, Wei L, Wang X, Tian Y, Duan R. Novel indicator for colonoscopy insertion difficulty and its application in predictive modelling: a multicentre prospective study protocol in China. BMJ Open. 2026 Jul 28;16(7):e120743. doi: 10.1136/bmjopen-2026-120743.
PubMed 42521303
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on a New Indicator for Assessing the Difficulty of Colonoscopy Insertion and Its Related Factors
- ClinicalTrials.gov ID
- NCT07228715
- Acronym / sponsor ID
- 2024467
- Conditions
- the Difficulty of Colonoscopy Insertion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Nov 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Junior Doctor Group | – | – |
| Senior Doctor Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo colonoscopy at the Second Hospital of Jilin University
Key inclusion criteria (1 listed)
- Patients who voluntarily undergo colonoscopy
Key exclusion criteria (1 listed)
- patients who failed to complete the colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time Required for Insertion to the Cecum (Cecal Intubation Time, CIT)
Time frame: From enrollment to the end of treatment at 1 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Results publication: PubMed 39138684Dincer 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.
- Results publication: PubMed 19136102Lai 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.
- Derived from this study: PubMed 42521303Zhang Y, Wei L, Wang X, Tian Y, Duan R. Novel indicator for colonoscopy insertion difficulty and its application in predictive modelling: a multicentre prospective study protocol in China. BMJ Open. 2026 Jul 28;16(7):e120743. doi: 10.1136/bmjopen-2026-120743.
- Individual participant dataSharing planned: No. Protect patients' privacy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 the Difficulty of Colonoscopy Insertion, run by Second Hospital of Jilin 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Required for Insertion to the Cecum (Cecal Intubation Time, CIT) (time frame: From enrollment to the end of treatment at 1 weeks). 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 NCT07228715, which also lists 3 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 14 Nov 2025.