NCT07685652

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 29, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

bowel preparation qualitycolonoscopyBoston Bowel Preparation Scalepatient educationvideo-based interventionwritten educational materialspolyp detectionendoscopy quality

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (9)

  • Polyp Detection Rate

    During colonoscopy procedure

  • Cecal Intubation Time

    During colonoscopy procedure

  • Colonoscopy Withdrawal Time

    During colonoscopy procedure

  • Procedure Cancellation Rate

    On day of scheduled colonoscopy

  • Repeat Colonoscopy Rate

    Within 6 months of initial colonoscopy

  • +4 more secondary outcomes

Study Arms (3)

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.

Behavioral: Verbal Counseling

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.

Behavioral: Tri-lingual Educational Pamphlet

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.

Behavioral: QR-Linked Instructional Videos

Interventions

Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.

Usual Care (Verbal Counseling)

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.

Written Educational Pamphlet

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.

Visual Media (QR Code Video)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sibu

Sibu, Sarawak, 96000, Malaysia

RECRUITING

Related Links

Study Officials

  • Prasad Mothayapan, MD

    Hospital Sibu, Malaysia

    PRINCIPAL INVESTIGATOR
  • Tiong How Chieng, MD

    Hospital Sibu, Malaysia

    STUDY DIRECTOR

Central Study Contacts

Prasad Mothayapan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations