NCT06444724

Brief Summary

The goal of this clinical trial is to learn about bowel preparation methods compared between standard techniques and enhanced education with application for elective colonoscopy. The main questions it aims to answer are: Which bowel preparation method results in an adequate bowel preparation rate? Participants will:

  • Random to 1:1 ratio to be educated via the smartphone application (APP group) or the standard education (control group).
  • Received the same purgative regimen and diet restriction.
  • Endoscopist-blinded colonoscopy the participants and give score of bowel preparation scale (use Boston Bowel Preparation Scale)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

May 27, 2024

Last Update Submit

September 27, 2025

Conditions

Keywords

ColonoscopySmartphone applicationBowel preparationQuality

Outcome Measures

Primary Outcomes (1)

  • Quality bowel preparation rate

    Quality bowel preparation will evaluated by Boston Bowel Preparation Scale score that over 6 points.

    The 1 day of colonoscpy

Secondary Outcomes (6)

  • Colonoscopy quality indicators : withdrawal time

    During the colonoscopy

  • Colonoscopy quality indicators : polyp detection rate

    During the colonoscopy

  • Colonoscopy quality indicators : adenoma detection rate

    During the colonoscopy and following the pathological result

  • Colonoscopy quality indicators : cecal intubation time

    During the colonoscopy

  • Patient satisfaction

    On the day of colonoscopy

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Patients in the control group received verbal instructions for bowel preparation before endoscopy from the endoscopy nurse, along with pamphlets containing relevant information. This instructional material encompassed details regarding a purgative regimen, instructions on its administration, dietary restrictions preceding colonoscopy, and medication adjustments necessary for some patients.

Application group

ACTIVE COMPARATOR

Patients in the application group will be communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.

Combination Product: APP

Interventions

APPCOMBINATION_PRODUCT

Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.

Also known as: Smartphone application
Application group

Eligibility Criteria

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

You may qualify if:

  • Patients aged over 18 with an indication for colonoscopy
  • Able to access and use Line applications on mobile phones

You may not qualify if:

  • Patients with a history of colonic resection
  • Patients with inflammatory bowel disease, polyposis syndrome, American Society of Anesthesiology (ASA) classification level 3 or higher
  • Patients with a history of prior colonoscopy within 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Using the Line application on the smartphone to communicate with the participant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 5, 2024

Study Start

July 1, 2022

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations