Improvement of Colonoscopy Preparation by Using a SPA

Colonoscopy Preparation Clinical Trial

— ColoprAPP  

Official title:

Evaluation of Improvement of Colonoscopy Preparation by Using a SPA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290157
• Other study ID #: ColoprAPP Study
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: May 28, 2019

Study information

• Verified date: February 2019
• Source: University of Ulm
• Contact: Benjamin M Walter, MD
• Phone: 0049-731-500-44818
• Email: Benjamin.walter[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).

Description:

Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy.

Although the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation.

A rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 28, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smartphone

• outpatient appointment for colonoscopy

• CRC Screening, surveillance

• <ASA 3

Exclusion Criteria:

• no smartphone

• >ASA 3 (no possibility for outpatient colonoscopy)

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

Device:
• ColoprAPP
Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

Locations

Country	Name	City	State
Germany	Gastroenterologische Praxis Dornstadt	Dornstadt
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Krankenhaus Ludwigsburg	Ludwigsburg
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Bowel preparation	Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation	During colonoscopy procedure
Secondary	Adenoma detection rate	Rate of adenoma detected and resected during colonoscopy	histological analysis after colonoscopy up to 10 days (d10)
Secondary	Acceptance of patients towards bowel preparation procedure	Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale	at colonoscopy appointment (day 0)