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ClinicalTrials.gov ID

NCT07582731

Lead Sponsor

Jie LiangOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

600Estimated

Last Update Posted

Jun 16, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jun 1, 2027Estimated

Completion Date

Jul 1, 2027Estimated

Official Title

A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease

Brief Summary

This multi-center, prospective, randomized controlled trial evaluates whether disease subtype-based active video education improves bowel preparation quality in patients with inflammatory bowel disease (IBD) undergoing colonoscopy. A total of 600 IBD patients from 13 centers will be randomized 1:1 to standard education plus subtype-specific video education (intervention group) or standard education alone (control group). The primary outcome is the Boston Bowel Preparation Scale (BBPS) score.

Detailed Description

Inflammatory bowel disease (IBD) patients often have suboptimal bowel preparation before colonoscopy due to chronic inflammation, strictures, and poor adherence to preparation protocols. Conventional written and verbal education has shown limited effectiveness in this population. This multi-center trial will develop and test an active video education intervention tailored to IBD subtypes (ulcerative colitis or Crohn's disease), delivered via WeChat before colonoscopy. A total of 600 patients from 13 participating hospitals across China will be randomized 1:1 to either the intervention group or the control group. Randomization will be stratified by center using a computer-generated sequence with allocation concealment (sealed, opaque envelopes). The primary endpoint is bowel preparation quality measured by the total BBPS score. Secondary outcomes include adequate/excellent preparation rates, cecal intubation rate and time, patient compliance, knowledge scores, adverse events, anxiety levels, and satisfaction. Outcome assessors will be blinded to group assignment to reduce bias. Statistical analyses will account for center effects (e.g., using mixed-effects models or including center as a covariate) and will be performed using appropriate methods based on data distribution.

• Inflammatory Bowel Diseases

• Disease Subtype-Based Active Video Education
• standard bowel preparation education

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Age between 18 and 75 years, inclusive.
2. Confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) according to standard clinical guidelines.
3. Scheduled for elective colonoscopy for IBD monitoring or disease activity assessment.
4. Able to understand written and verbal instructions and to use a smartphone to view video education materials.
5. Voluntary participation with written informed consent.

Exclusion Criteria:

1. Absolute contraindications to colonoscopy, including acute gastrointestinal perforation, fulminant colitis, toxic megacolon, or hemodynamic instability.
2. History of total or subtotal colectomy.
3. Acute or chronic intestinal obstruction.
4. Severe cardiac, pulmonary, hepatic, or renal insufficiency (eGFR <30 mL/min/1.73m², NYHA class III/IV).
5. Severe psychiatric or cognitive impairment that prevents understanding of the study requirements.
6. Inability or unwillingness to provide written informed consent.
7. Pregnant or breastfeeding women.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Jie LiangOTHER

Collaborators

Xijing Hospital of Digestive DiseasesOTHER

Peking Union Medical College HospitalOTHER

Shengjing HospitalOTHER

RenJi HospitalOTHER

Changhai HospitalOTHER

First Affiliated Hospital of Xinjiang Medical UniversityOTHER

Affiliated Hospital of Qinghai UniversityOTHER

Second Affiliated Hospital of Xi'an Jiaotong UniversityOTHER

Air Force 986 HospitalOTHER

Shanxi Yuncheng Central HospitalUNKNOWN

Ruijin HospitalOTHER

Changzhi Medical CollegeOTHER

Linfen Central HospitalOTHER

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