Bowel Preparation, Colonoscopy, Quality, Smartphone Application
Conditions
Keywords
Colonoscopy, Smartphone application, Bowel preparation, Quality
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)
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.
Interventions
COMBINATION_PRODUCTAPP
Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Using the Line application on the smartphone to communicate with the participant
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality bowel preparation rate | The 1 day of colonoscpy | Quality bowel preparation will evaluated by Boston Bowel Preparation Scale score that over 6 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopy quality indicators : polyp detection rate | During the colonoscopy | Number of polyps detected during the scope withdrawal |
| Colonoscopy quality indicators : adenoma detection rate | During the colonoscopy and following the pathological result | Number of adenoma (proof by pathology) detected during the scope withdrawal |
| Colonoscopy quality indicators : withdrawal time | During the colonoscopy | The duration of scope withdrawal in the exception of the time used for therapeutic intervention |
| Patient satisfaction | 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) |
| Side effects of bowel preparation | On the day of colonoscopy | Side effects of bowel preparation will access by questionnaire |
| Colonoscopy quality indicators : cecal intubation time | During the colonoscopy | The duration of scope insertion from anus to cecum |
Countries
Thailand
Outcome results
None listed