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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APP | Combination Product | Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of internal medicine siriraj hospital, Mahidol university | Bangkok Noi | Bangkok | 10700 | Thailand |
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Using the Line application on the smartphone to communicate with the participant
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|
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 |