Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444724
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-27
Brief Title:
The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
Which bowel preparation method results in an adequate bowel preparation rate
Participants will
Random to 11 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 11 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None