ColonoscopyPhase 4NCT06444724
The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
A Phase 4 study testing APP in people with Colonoscopy and Bowel Preparation, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Bowel Preparation, Quality
- What is being tested?
- APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to 28 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 with an indication for colonoscopy
- Able to access and use Line applications on mobile phones
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700
About this study
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)
Read the 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.
- Conditions
- Colonoscopy, Bowel Preparation, Quality, Smartphone Application
- Being tested
- APP
- Keywords
- Colonoscopy, Smartphone application, Bowel preparation, Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPCombination product
Also called Smartphone application
Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality bowel preparation rate
Quality bowel preparation will evaluated by Boston Bowel Preparation Scale score that over 6 points.
Measured: The 1 day of colonoscpy
Secondary outcomes (6)
Colonoscopy quality indicators : withdrawal time
The duration of scope withdrawal in the exception of the time used for therapeutic intervention
Measured: During the colonoscopy
Colonoscopy quality indicators : polyp detection rate
Number of polyps detected during the scope withdrawal
Measured: During the colonoscopy
Colonoscopy quality indicators : adenoma detection rate
Number of adenoma (proof by pathology) detected during the scope withdrawal
Measured: During the colonoscopy and following the pathological result
Colonoscopy quality indicators : cecal intubation time
The duration of scope insertion from anus to cecum
Measured: 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)
Measured: On the day of colonoscopy
Side effects of bowel preparation
Side effects of bowel preparation will access by questionnaire
Measured: On the day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using the Line application on the smartphone to communicate with the participant
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uayporn Kaosombatwattana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444724
- Sponsor's protocol ID
- Si 422/2022
- Status last verified
- Sep 2025
- First submitted
- 27 May 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT06444724
- Acronym / sponsor ID
- Si 422/2022
- Conditions
- Colonoscopy, Bowel Preparation, Quality, Smartphone Application
- Keywords
- Colonoscopy, Smartphone application, Bowel preparation, Quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Using the Line application on the smartphone to communicate with the participant
| Arm | Type | Receives |
|---|---|---|
| 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 | Combination Product: APPPatients in the application group will be communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 18 with an indication for colonoscopy
- Able to access and use Line applications on mobile phones
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPAlso: Smartphone applicationPatients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media. | Combination product | Application group |
Primary outcome
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.
6 secondary outcomes
Colonoscopy quality indicators : withdrawal time
Time frame: During the colonoscopy
Colonoscopy quality indicators : polyp detection rate
Time frame: During the colonoscopy
Colonoscopy quality indicators : adenoma detection rate
Time frame: During the colonoscopy and following the pathological result
Colonoscopy quality indicators : cecal intubation time
Time frame: During the colonoscopy
Patient satisfaction
Time frame: On the day of colonoscopy
Side effects of bowel preparation
Time frame: On the day of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing APP in people with Colonoscopy and Bowel Preparation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality bowel preparation rate (time frame: The 1 day of colonoscpy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.