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| ID | Type | Description | Link |
|---|---|---|---|
| NMRR-25-04038-EOB | Registry Identifier | Malaysian National Medical Research Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (Verbal Counseling) | Active Comparator | Standard physician/nurse-delivered verbal instructions and standard pharmacy information sheet for bowel preparation solution (split-dose PEG 3L, Fortrans) according to hospital protocol. Timing and dietary guidance aligned with standard of care. No additional written or visual materials provided. |
|
| Written Educational Pamphlet | Experimental | Tri-lingual (Malay, English, Chinese) plain-language educational pamphlet detailing step-by-step bowel preparation instructions, plus brief verbal explanation. Pamphlet reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. |
|
| Visual Media (QR Code Video) | Experimental | Short, structured instructional videos accessible via smartphone QR code explaining bowel preparation procedure step-by-step, plus brief verbal explanation. Videos reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verbal Counseling | Behavioral | Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS) | 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. | On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection Rate | Proportion of participants with at least one polyp detected during colonoscopy. Documented as yes/no and number of polyps. | During colonoscopy procedure |
| Cecal Intubation Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prasad Mothayapan, MD | Contact | +60-84-343333 | mprasad.ge@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prasad Mothayapan, MD | Hospital Sibu, Malaysia | Principal Investigator |
| Tiong How Chieng, MD | Hospital Sibu, Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sibu | Recruiting | Sibu | Sarawak | 96000 | Malaysia |
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| Label | URL |
|---|---|
| Colonoscopy preparation videos | View source |
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Individual Participant Data will not be made publicly available. De-identified aggregate study data may be available upon reasonable request after publication, subject to institutional approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2026 |
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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.
| Tri-lingual Educational Pamphlet | Behavioral | 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. |
|
| QR-Linked Instructional Videos | Behavioral | 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. |
|
Time in minutes from colonoscope insertion to identification of cecal landmarks.
| During colonoscopy procedure |
| Colonoscopy Withdrawal Time | Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time. | During colonoscopy procedure |
| Procedure Cancellation Rate | Proportion of participants whose colonoscopy was cancelled and reason for cancellation. | On day of scheduled colonoscopy |
| Repeat Colonoscopy Rate | Proportion requiring repeat colonoscopy due to inadequate initial preparation. | Within 6 months of initial colonoscopy |
| Patient Tolerance to Bowel Preparation | atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult. | Pre-procedure on day of colonoscopy |
| Procedure-Related Complications | 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. | During procedure and within 7 days post-procedure |
| Patient-Reported Clarity of Instructions | 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). | Pre-procedure on day of colonoscopy |
| Patient Anxiety Assessment | Patient self-reported anxiety on Visual Analog Scale for Anxiety (VAS-A), 0-10 scale (0=no anxiety, 10=extremely anxious). | Pre-procedure on day of colonoscopy |
| Jun 25, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 24, 2025 | Jun 25, 2026 | ICF_001.pdf |