The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy

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)

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation; Smartphone Application; Quality
• Intervention / Treatment: Combination product: APP

Detailed Description

A prospective, endoscopist-blinded, randomized, controlled trial will conducted at the GI endoscopy center, Siriraj Hospital, Bangkok, Thailand. Patients will be divided into 2 groups in a 1:1 ratio using a computer-generated randomization method, with a block of four randomizations. Written informed consent will be obtained from all participants before their enrolment in the study.

• Patients in the control group received verbal instructions for 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.
• Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.

The registration process will entail providing basic information, including the patient's name and hospital identification number, along with the scheduled endoscopy appointment date, with strict adherence to privacy protocols. Subsequently, a trained research assistant will encourage patients to utilize the application. The video can inform the application via YouTube.

The content presented in the video corresponded identically to the verbal instructions and pamphlet provided to participants in the control group, covering topics such as the purgative regimen, dietary restrictions, and medication adjustments.

All participants will receive the same split-dose high-volume purgative regimen. Two liters of polyethylene glycol (PEG) solution regarding the composition of Colyte (hospital-based preparations) will be administered at 6-8 PM on the day before the colonoscopy, followed by 750 ml of PEG solution at 5-6 AM on the colonoscopy day.

Colonoscopies will be performed by an experienced endoscopist under intravenous sedation within 6 hours after the last preparation regimen.

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of internal medicine siriraj hospital, Mahidol university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Active Comparator: Application group; 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; Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.; Other Names: Smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy quality indicators : withdrawal time	The duration of scope withdrawal in the exception of the time used for therapeutic intervention	During the colonoscopy
Colonoscopy quality indicators : polyp detection rate	Number of polyps detected during the scope withdrawal	During the colonoscopy
Colonoscopy quality indicators : adenoma detection rate	Number of adenoma (proof by pathology) detected during the scope withdrawal	During the colonoscopy and following the pathological result
Colonoscopy quality indicators : cecal intubation time	The duration of scope insertion from anus to cecum	During the colonoscopy
Patient satisfaction	Evaluation of patient satisfaction with the bowel preparation protocol using the visual analog scale (Likert scale), which range from 1 (least satisfaction) to 5 (most satisfaction)	On the day of colonoscopy
Side effects of bowel preparation	Side effects of bowel preparation will access by questionnaire	On the day of colonoscopy

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Colonoscopy; Quality; Smartphone application; Bowel preparation
• Other Study ID Numbers: Si 422/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No