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NCT Number: NCT07582731

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Beijing, BeijingBeijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Disease Subtype-Based Active Video Education

Behavioral

A structured, subtype-specific educational video program tailored for patients with inflammatory bowel disease (IBD). The videos are customized based on IBD subtype (ulcerative colitis/Crohn's disease), disease activity (active/remission), and Crohn's disease behavior (stricturing/fistulizing). It covers key topics including dietary restrictions, laxative intake instructions, symptom management, and practical problem-solving strategies to improve understanding and adherence to bowel preparation protocols. The video is delivered via WeChat link.

Other names: WeChat-Based Personalized IBD Video Education

standard bowel preparation education

Behavioral

standard bowel preparation education

Primary outcomes

  1. Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)

    Time frame: Periprocedural (during colonoscopy)

    The Boston Bowel Preparation Scale (BBPS) is a validated scoring system to assess the cleanliness of three colonic segments: right colon (including cecum and ascending colon), transverse colon (including hepatic flexure and splenic flexure), and left colon (including descending colon, sigmoid colon, and rectum). Each segment is scored from 0 (unprepared) to 3 (excellent) by the endoscopist during withdrawal. The total BBPS score ranges from 0 to 9. Higher scores indicate better bowel preparation.

Secondary outcomes

  1. Adequate Bowel Preparation Rate

    Time frame: Periprocedural (during colonoscopy)

    Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6.

  2. Excellent Bowel Preparation Rate

    Time frame: Periprocedural (during colonoscopy)

    Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.

  3. Cecal Intubation Rate

    Time frame: Periprocedural (during colonoscopy)

    Proportion of patients in whom the cecum is successfully intubated during colonoscopy.

  4. Cecal Intubation Time

    Time frame: Periprocedural (during colonoscopy)

    Time (in seconds) required to reach and intubate the cecum, measured from the time the colonoscope is inserted until cecal intubation is confirmed.

  5. Bowel Preparation Compliance Rate

    Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)

    Three adherence measures: (1) dietary restriction compliance (yes/no), (2) laxative intake completion (≥75% of prescribed dose as yes), (3) video viewing completion (intervention group only, at least one full viewing).

  6. Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat

    Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)

    Assessed via patient-reported questionnaire using visual analog scales or Likert scales (0-10). Components: pre-procedural anxiety level, tolerance of bowel preparation process, overall satisfaction, and willingness to repeat colonoscopy if needed.

  7. Incidence of Adverse Events

    Time frame: During bowel preparation and up to 7 days post-colonoscopy

    Number and proportion of patients experiencing adverse events related to bowel preparation, including nausea, vomiting, abdominal pain, bloating, and electrolyte abnormalities.

  8. Bowel Preparation Knowledge Score

    Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)

    Patient knowledge about bowel preparation assessed using a 0-10 point questionnaire, with higher scores indicating better knowledge.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Liang, MD, PhD

CONTACT

[email protected]

029-84771535

Sponsors and collaborators

Lead sponsor

Jie Liang

Other

Collaborators

  • Affiliated Hospital of Qinghai University
  • Air Force 986 Hospital
  • Changhai Hospital
  • Changzhi Medical College
  • First Affiliated Hospital of Xinjiang Medical University
  • Peking Union Medical College Hospital
  • RenJi Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanxi Yuncheng Central Hospital
  • Shengjing Hospital
  • The Central Hospital of Linfen
  • Xijing Hospital of Digestive Diseases

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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