Inflammatory Bowel Diseases
Conditions
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.
Interventions
BEHAVIORALDisease Subtype-Based Active Video Education
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.
BEHAVIORALstandard bowel preparation education
standard bowel preparation education
Sponsors
Jie Liang
Xijing Hospital of Digestive Diseases
Peking Union Medical College Hospital
Shengjing Hospital
RenJi Hospital
Changhai hospital of Navy Medical University
First Affiliated Hospital of Xinjiang Medical University
Affiliated Hospital of Qinghai University
Second Affiliated Hospital of Xi'an Jiaotong University
Air Force 986 Hospital
Shanxi Yuncheng Central Hospital
Ruijin Hospital
Changzhi Medical College
The Central Hospital of Linfen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors (endoscopists evaluating bowel preparation quality and research staff collecting data) will be blinded to participants' group assignment to minimize assessment bias.
Intervention model description
This multi-center trial (13 centers) uses center-stratified randomization with a 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Adequate Bowel Preparation Rate | Periprocedural (during colonoscopy) | Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6. |
| Excellent Bowel Preparation Rate | Periprocedural (during colonoscopy) | Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8. |
| Cecal Intubation Rate | Periprocedural (during colonoscopy) | Proportion of patients in whom the cecum is successfully intubated during colonoscopy. |
| Cecal Intubation Time | 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. |
| Bowel Preparation Compliance Rate | 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). |
| Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat | 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. |
| Incidence of Adverse Events | 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. |
| Bowel Preparation Knowledge Score | 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. |
Countries
China
Contacts
CONTACTJie Liang, MD, PhD
Outcome results
None listed