Improvement of Colonoscopy Preparation by Using a SPA

Not Applicable

• Conditions: Colonoscopy Preparation
• Interventions: Device: ColoprAPP

• Registration Number: NCT03290157
• Lead Sponsor: University of Ulm

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-21
• Study Start: 2017-10-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-03-30
• Study Completion: 2019-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• smartphone
• outpatient appointment for colonoscopy
• CRC Screening, surveillance
• <ASA 3

Exclusion Criteria

• no smartphone
• >ASA 3 (no possibility for outpatient colonoscopy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ColoprAPP group	ColoprAPP	Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation

Primary Outcome Measures

Name	Time	Method
Quality of Bowel preparation	During colonoscopy procedure	Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate	histological analysis after colonoscopy up to 10 days (d10)	Rate of adenoma detected and resected during colonoscopy
Acceptance of patients towards bowel preparation procedure	at colonoscopy appointment (day 0)	Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale

Trial Locations

Locations (4)

Gastroenterologische Praxis Dornstadt; 🇩🇪 Dornstadt, Germany

Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Krankenhaus Ludwigsburg; 🇩🇪 Ludwigsburg, Germany