Patients Judging Bowel Preparation by Using SMARTPHONE Application

BOWEL PREPARATION (BOWEL CLEANSING) Clinical Trial

— BPBUSA  

Official title:

Patients Judging Dose Adjustment of Bowel Preparation Solution for Bowel Preparation by Using SMARTPHONE Application: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01937819
• Other study ID #: SMART-BP01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 4, 2013
• Last updated: September 4, 2013
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: Inje University
• Contact: Jongha Park, M.D.
• Phone: +82-51-797-0200
• Email: neakker[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.

Description:

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of SMARTPHONE application on the bowel cleansing was inspected.

A intervention patients take the picture of stool using SMARTPHONE camera application, and then assess the bowel cleansing result. If the result is "Pass", they stop the addition of bowel preparation agent. but the result is "Fail", so they have the additive bowel preparation agent and repeat using the SMARTPHONE application.

After the bowel preparation, Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale after procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera

Exclusion Criteria:

• known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• BOWEL PREPARATION (BOWEL CLEANSING)

Intervention

Device:
• SMART arm
The SMARTPHONE application for self judging bowel preparation by taking the picture of stool form.

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleaning quality according to Ottawa scale scores		3 months	No
Secondary	The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy		3 months	No