Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

NCT06878378 | Recruiting

• 1 other identifier: CHEC2025-083
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colonoscopy; Colonoscopy: Bowel Preparation

Keywords

bowel preparation; colonoscopy

Outcome Measures

Primary Outcomes (1)

• adequate bowel preparation rate

  The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary Outcomes (1)

• adenoma detection rate

  1 year

Study Arms (1)

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.

Other: Investigation of Factors Influencing Bowel Preparation Quality

Interventions

Investigation of Factors Influencing Bowel Preparation Quality OTHER

Observed parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols.

outpatients and inpatients scheduled for colonoscopy or polypectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients aged \>18 years, regardless of gender, scheduled for colonoscopy
• Written informed consent has been obtained

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Zhao-shen Li

CONTACT

0086-13386273620; zhaoshenli@hotmail.com

Zi-xuan He

CONTACT

0086-15901597359; zixuan931004@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 17, 2025
• Study Start: February 21, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

CN (1)