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RecruitingNCT07335705

Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients

Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Changhai Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.

Detailed description

Step 1: During the issuance of a colonoscopy order, outpatient/ward physicians conduct preliminary screening and introduction to potential participants. Alternatively, recruitment may take place during follow-up in the recovery room or ward after the patient completes the colonoscopy (must be within 7 days post-procedure to reduce recall bias). Provide detailed explanations of the study content, risks, and benefits to potential subjects. Step 2: Ensure that the patient fully understands the study, and then proceed to sign the "Informed Consent Form." Step 3: Patients complete the "Questionnaire on Factors Influencing Bowel Preparation in IBD Patients." The questionnaire covers two main aspects: First, potential risk factors that may affect the quality of bowel preparation, including BMI, history of abdominal surgery, history of diabetes, history of diarrhea or constipation, stool characteristics, etc. Second, the specific bowel preparation protocol, including pre-colonoscopy diet, type of bowel cleansing agent used, dosage, interval between completion of medication and start of colonoscopy (waiting time), timing of medication intake, etc. Finally, the researcher records the bowel preparation quality score and colonoscopy results, including Boston Bowel Preparation Scale scores for each intestinal segment, colonoscopic diagnosis, endoscopic disease activity scores, etc.

Conditions

Interventions

TypeNameDescription
OTHERStandard Pre-colonoscopy Bowel Preparation ProtocolThis involves standard clinical instructions including a low-residue diet prior to colonoscopy and the administration of bowel cleansing agents (e.g., Polyethylene Glycol) according to the split-dose regimen as per each participating center's routine practice. The timing, dosage, and specific agent used follow existing institutional guidelines.

Timeline

Start date
2025-12-08
Primary completion
2026-10-01
Completion
2026-10-01
First posted
2026-01-13
Last updated
2026-01-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07335705. Inclusion in this directory is not an endorsement.