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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Colonoscopy: Bowel Preparation; IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Other: Standard Pre-colonoscopy Bowel Preparation Protocol

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Zi-xuan He, M.D.; Email: zixuan931004@163.com
• Study Contact Backup: Name: Zhao-shen Li, M.D.; Phone Number: 13386273620; Email: zhaoshenli@hotmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Zhao-shen Li; Phone Number: 13386273620; Email: zhaoshenli@hotmail.com
      • Contact: Zi-xuan He; Email: zixuan931004@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

adult patients (aged ≥18 years) diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 Chinese guidelines, who are scheduled to undergo a colonoscopy

Description

Inclusion Criteria:

• Patients aged 18 years or older, of any gender, scheduled for colonoscopy;
• Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
• Voluntary participation in this study and provision of signed informed consent.

Exclusion Criteria:

• History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;
• Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;
• Pregnant or lactating women;
• Acute intestinal infection within the past 2 weeks;
• History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;
• History of intestinal obstruction, perforation, stenosis, or any other condition preventing completion of the examination;
• Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the survey;
• Individuals already enrolled in this study who schedule a repeat colonoscopy;
• Currently participating in another clinical observational trial or having participated in any other clinical trial within the past 60 days;
• Refusal to sign the written informed consent form.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational Cohort for Bowel Preparation in IBD Patients; Patients aged 18 years or older diagnosed with Inflammatory Bowel Disease (IBD) and scheduled for a colonoscopy, who undergo standard bowel preparation procedures followed by colonoscopy examination and questionnaire completion.

Other: Standard Pre-colonoscopy Bowel Preparation Protocol; This 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adequate bowel preparation rate	Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.	The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction is rated on a 5-point Likert scale ranging from 0 (very dissatisfied) to 5 (very satisfied), with patients rating their satisfaction regarding the entire bowel preparation process from the day before to immediately before the colonoscopy.	immediately upon completion of colonoscopy

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Xijing Hospital; First People's Hospital of Hangzhou; The First Affiliated Hospital of Anhui Medical University; RenJi Hospital; The Affiliated Hospital of Qingdao University; Shanghai 10th People's Hospital; Ruijin Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; ShuGuang Hospital; Subei People's Hospital of Jiangsu Province; Jiangmen Central Hospital; Ankang Central Hospital; Shengli Oilfield Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; IBD; Bowel preparation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: CHEC2025-448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No