The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy

Colonoscopy Clinical Trial

Official title:

The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444724
• Other study ID #: Si 422/2022
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: Uayporn Kaosombatwattana, MD
• Phone: +66619245953
• Email: koigi214[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Quality
• Smartphone Application

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of internal medicine siriraj hospital, Mahidol university	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality bowel preparation rate	Quality bowel preparation will evaluated by Boston Bowel Preparation Scale score that over 6 points.	The 1 day of colonoscpy
Secondary	Colonoscopy quality indicators : withdrawal time	The duration of scope withdrawal in the exception of the time used for therapeutic intervention	During the colonoscopy
Secondary	Colonoscopy quality indicators : polyp detection rate	Number of polyps detected during the scope withdrawal	During the colonoscopy
Secondary	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
Secondary	Colonoscopy quality indicators : cecal intubation time	The duration of scope insertion from anus to cecum	During the colonoscopy
Secondary	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
Secondary	Side effects of bowel preparation	Side effects of bowel preparation will access by questionnaire	On the day of colonoscopy