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Completed

NCT Number: NCT06444724

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)

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Key information

Conditions

Colonoscopy Bowel Preparation Quality Smartphone Application

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APP

Combination Product

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

Other names: Smartphone application

Primary outcomes

  1. Quality bowel preparation rate

    Time frame: The 1 day of colonoscpy

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

Secondary outcomes

  1. Colonoscopy quality indicators : withdrawal time

    Time frame: During the colonoscopy

    The duration of scope withdrawal in the exception of the time used for therapeutic intervention

  2. Colonoscopy quality indicators : polyp detection rate

    Time frame: During the colonoscopy

    Number of polyps detected during the scope withdrawal

  3. Colonoscopy quality indicators : adenoma detection rate

    Time frame: During the colonoscopy and following the pathological result

    Number of adenoma (proof by pathology) detected during the scope withdrawal

  4. Colonoscopy quality indicators : cecal intubation time

    Time frame: During the colonoscopy

    The duration of scope insertion from anus to cecum

  5. Patient satisfaction

    Time frame: On the day of colonoscopy

    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)

  6. Side effects of bowel preparation

    Time frame: On the day of colonoscopy

    Side effects of bowel preparation will access by questionnaire

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 5, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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