Bowel Preparation Quality, Colonoscopy, Patient Education Materials
Conditions
Keywords
bowel preparation quality, colonoscopy, Boston Bowel Preparation Scale, patient education, video-based intervention, written educational materials, polyp detection, endoscopy quality
Brief summary
High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. This study compares three common patient education modalities-usual care verbal counseling, written tri-lingual pamphlet, and visual media via smartphone QR code-to determine which yields the best bowel preparation quality as assessed by the Boston Bowel Preparation Scale (BBPS) in an outpatient endoscopy setting.
Detailed description
BACKGROUND AND RATIONALE: Non-pharmacological factors, especially the modality of patient education, may influence bowel preparation quality, yet are underexplored and likely context-dependent based on local staffing, patient characteristics, and practice norms. STUDY DESIGN: Prospective, single-endoscopist-blinded, three-arm randomized controlled trial (RCT) with intention-to-treat (ITT) primary analysis. Allocation 1:1:1 using computer-generated random numbers. Endoscopist and endoscopy nurses are blinded to group assignment; participants cannot be blinded due to the nature of the intervention. SETTING: Hospital Sibu Endoscopy Unit, Sarawak, Malaysia. Colonoscopies performed by qualified surgeons or registrars under supervision; all endoscopists undergo refresher training on Boston Bowel Preparation Scale (BBPS) scoring for consistency. STUDY ARMS (INTERVENTIONS): Arm A (Control): Usual care. Physician/nurse-delivered verbal instructions plus standard pharmacy instructions for bowel preparation solution (split-dose PEG 3L). Arm B (Written): Tri-lingual (Malay/English/Chinese), plain-language educational leaflet reviewed by health literacy expert, plus brief verbal explanation. Arm C (Visual): Short, structured instructional videos accessible via smartphone QR code, reviewed by health literacy expert, plus brief verbal explanation. SAMPLE SIZE AND STATISTICAL ANALYSIS: N=324 (108 per arm). Primary analysis: Intent-to-treat chi-square test comparing adequate vs inadequate BBPS across three arms. Pairwise comparisons with Bonferroni adjustment. Multivariable logistic regression adjusts for prespecified covariates (age, sex, BMI, diabetes, education, language, constipation, study arm). PRIMARY OUTCOME: Adequate versus inadequate bowel preparation on Boston Bowel Preparation Scale (BBPS). Adequate = total ≥6 with all segments ≥2. SECONDARY OUTCOMES: Polyp detection rate; cecal intubation and withdrawal times; cancellation and repeat rates; patient tolerance; complications; patient-reported clarity and helpfulness; anxiety (VAS-A); demographic predictors.
Interventions
BEHAVIORALVerbal Counseling
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
BEHAVIORALTri-lingual Educational Pamphlet
Structured written educational material in Malay, English, and Chinese languages detailing complete bowel preparation instructions, timing, dietary guidance, what to expect, and troubleshooting tips. Provided to participant with brief verbal explanation.
BEHAVIORALQR-Linked Instructional Videos
Short, professionally produced instructional videos accessible via smartphone QR code link. Videos present step-by-step bowel preparation instructions, timing, dietary guidance, common concerns, and what to expect during procedure. Participant scans QR code to access video(s) on their smartphone.
Sponsors
Sibu Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Endoscopist and endoscopy nurses blinded to participant group allocation during procedure and BBPS assessment. Participants and education staff unblinded due to nature of educational intervention. Outcome assessors record BBPS before any bowel cleansing attempts.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Outpatients scheduled for elective colonoscopy at Hospital Sibu Endoscopy Unit * Ability to provide written informed consent * Access to smartphone or computer with functional internet connectivity
Exclusion criteria
* History of non-compliance with prescribed medical regimens * Cognitive impairment, dementia, or significant mental health disorder compromising informed consent * Illiteracy or inability to read materials in provided languages * Prior colonic resection or colostomy * Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS) * Significant physical disability (bed-bound or wheelchair-dependent) * Contraindication to polyethylene glycol (PEG) bowel preparation * Severe Chronic Kidney Disease (Stage IV or V; eGFR \<15 mL/min/1.73m²) * Significant cardiac comorbidities (unstable angina, severe heart failure, MI within 6 months) * Inability or unwillingness to comply with study protocol * Refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS) | On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes) | Primary outcome dichotomized as adequate versus inadequate bowel preparation. Adequate = total BBPS score ≥6 with all three colon segments (left, transverse, right) scoring ≥2 each (scale 0-3 per segment; range 0-9). Inadequate = total \<6 or any segment \<2. Assessment performed before any bowel cleansing/lavage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp Detection Rate | During colonoscopy procedure | Proportion of participants with at least one polyp detected during colonoscopy. Documented as yes/no and number of polyps. |
| Cecal Intubation Time | During colonoscopy procedure | Time in minutes from colonoscope insertion to identification of cecal landmarks. |
| Colonoscopy Withdrawal Time | During colonoscopy procedure | Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time. |
| Procedure Cancellation Rate | On day of scheduled colonoscopy | Proportion of participants whose colonoscopy was cancelled and reason for cancellation. |
| Repeat Colonoscopy Rate | Within 6 months of initial colonoscopy | Proportion requiring repeat colonoscopy due to inadequate initial preparation. |
| Patient Tolerance to Bowel Preparation | Pre-procedure on day of colonoscopy | atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult. |
| Procedure-Related Complications | During procedure and within 7 days post-procedure | Occurrence of procedure-related complications including perforation, bleeding, post-polypectomy syndrome, or other adverse events. Outcome is dichotomous: Yes (complication occurred) or No (no complications). Lower occurrence rate indicates better outcome. |
| Patient-Reported Clarity of Instructions | Pre-procedure on day of colonoscopy | Patient perception of clarity using Five-Point Likert Scale (minimum=1 "Strongly Disagree", maximum=5 "Strongly Agree"). Statement: "The instructions were clear." Higher scores indicate greater perceived clarity of instructions (better outcome). |
| Patient Anxiety Assessment | Pre-procedure on day of colonoscopy | Patient self-reported anxiety on Visual Analog Scale for Anxiety (VAS-A), 0-10 scale (0=no anxiety, 10=extremely anxious). |
Countries
Malaysia
Contacts
CONTACTPrasad Mothayapan, MD
PRINCIPAL_INVESTIGATORPrasad Mothayapan, MD
Hospital Sibu, Malaysia
STUDY_DIRECTORTiong How Chieng, MD
Hospital Sibu, Malaysia
Outcome results
None listed