ColonoscopyNCT06878378
Risk Factors for Inadequate Bowel Preparation Before Colonoscopy
An observational study of Colonoscopy and Colonoscopy: Bowel Preparation, run by Changhai Hospital at 1 site in China.
Trial summary
The primary objectives of this study are twofold: Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colonoscopy: Bowel Preparation
- What is being tested?
- Investigation of Factors Influencing Bowel Preparation Quality
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to 1 Feb 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and February 2026.
Who may be able to join
- Patients aged >18 years, regardless of gender, scheduled for colonoscopy
- Written informed consent has been obtained
Who cannot join
- History of acute myocardial infarction (within 6 months), severe cardiac/hepatic/renal insufficiency, or psychiatric disorders
- Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders
- Pregnancy or lactation;
- History of inflammatory bowel disease or acute intestinal infection within the past 2 weeks;
- History of colorectal cancer, familial adenomatous polyposis (FAP), or Peutz-Jeghers syndrome;
- History of intestinal obstruction, perforation, stricture, or other conditions precluding completion of colonoscopy;
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- Non-compliance with bowel preparation protocols (e.g., ingestion of <80% of prescribed polyethylene glycol (PEG) electrolyte solution);
- Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the study;
- Prior enrollment in this study with a repeat colonoscopy appointment;
- Current participation in other clinical trials or participation in any trial within the preceding 60 days;
- Refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhao-shen Li, 0086-13386273620, zhaoshenli@hotmail.com
Zi-xuan He, 0086-15901597359, zixuan931004@163.com
About this study
Official title: Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study
The primary objectives of this study are twofold:
Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. This aims to standardize and optimize bowel preparation protocols nationwide.
Secondly, to identify and analyze risk factors contributing to suboptimal bowel preparation quality in patients undergoing colonoscopy. The study will examine the correlation between these factors and bowel preparation scores, establish a risk prediction model for preparation failure, and provide a theoretical foundation for developing personalized bowel preparation regimens tailored to individual patient characteristics.
Read the detailed description
The project is divided into three key phases:
- Initiation Phase: Develop a Bowel Preparation Assessment Questionnaire (BPAQ) to standardize data collection. Establish collaborative centers (multicenter hospitals) nationwide for coordinated implementation.
- Implementation Phase: Conduct on-site audits to evaluate bowel preparation practices across participating centers. Deliver protocol-specific training to healthcare providers, emphasizing compliance with the 2023 guidelines. Systematically collect bowel preparation data, including patient demographics, protocol adherence metrics, and clinical outcomes.
- Conclusion Phase:
Prioritize data quality assurance through dual-entry validation and logic checks to ensure authenticity, comprehensiveness, and objectivity.
Generate consolidated reports to identify systemic gaps and propose evidence-based optimization strategies.
- Conditions
- Colonoscopy, Colonoscopy: Bowel Preparation
- Being tested
- Investigation of Factors Influencing Bowel Preparation Quality
- Keywords
- bowel preparation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of Factors Influencing Bowel Preparation QualityOther
Observed parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols.
| Study group | Role | What they receive |
|---|---|---|
| outpatients and inpatients scheduled for colonoscopy or polypectomy | The target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and December 2026. Data from these individuals will be collected to assess factors influencing bowel preparation quality. Receives: Other: Investigation of Factors Influencing Bowel Preparation Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate bowel preparation rate
Measured: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
Secondary outcomes (1)
adenoma detection rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start21 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878378
- Sponsor's protocol ID
- CHEC2025-083
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06878378
- Acronym / sponsor ID
- CHEC2025-083
- Conditions
- Colonoscopy, Colonoscopy: Bowel Preparation
- Keywords
- bowel preparation, colonoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 Mar 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.
The primary objectives of this study are twofold:
Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. This aims to standardize and optimize bowel preparation protocols nationwide.
Secondly, to identify and analyze risk factors contributing to suboptimal bowel preparation quality in patients undergoing colonoscopy. The study will examine the correlation between these factors and bowel preparation scores, establish a risk prediction model for preparation failure, and provide a theoretical foundation for developing personalized bowel preparation regimens tailored to individual patient characteristics.
Detailed description
The project is divided into three key phases:
- Initiation Phase: Develop a Bowel Preparation Assessment Questionnaire (BPAQ) to standardize data collection. Establish collaborative centers (multicenter hospitals) nationwide for coordinated implementation.
- Implementation Phase: Conduct on-site audits to evaluate bowel preparation practices across participating centers. Deliver protocol-specific training to healthcare providers, emphasizing compliance with the 2023 guidelines. Systematically collect bowel preparation data, including patient demographics, protocol adherence metrics, and clinical outcomes.
- Conclusion Phase:
Prioritize data quality assurance through dual-entry validation and logic checks to ensure authenticity, comprehensiveness, and objectivity.
Generate consolidated reports to identify systemic gaps and propose evidence-based optimization strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatients and inpatients scheduled for colonoscopy or polypectomy | – | Other: Investigation of Factors Influencing Bowel Preparation QualityThe target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and December 2026. Data from these individuals will be collected to assess factors influencing bowel preparation quality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and February 2026.
Key inclusion criteria (2 listed)
- Patients aged >18 years, regardless of gender, scheduled for colonoscopy
- Written informed consent has been obtained
Key exclusion criteria (11 listed)
- History of acute myocardial infarction (within 6 months), severe cardiac/hepatic/renal insufficiency, or psychiatric disorders
- Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders
- Pregnancy or lactation;
- History of inflammatory bowel disease or acute intestinal infection within the past 2 weeks;
- History of colorectal cancer, familial adenomatous polyposis (FAP), or Peutz-Jeghers syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigation of Factors Influencing Bowel Preparation QualityObserved parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols. | Other | outpatients and inpatients scheduled for colonoscopy or polypectomy |
Primary outcome
adequate bowel preparation rate
Time frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
1 secondary outcome
adenoma detection rate
Time frame: 1 year
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 18 Mar 2025.
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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.
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 Colonoscopy and Colonoscopy: Bowel Preparation, run by Changhai Hospital 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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Mar 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?
Contact Zhao-shen Li (0086-13386273620, zhaoshenli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate bowel preparation rate (time frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.