Clinical trial NCT03290157: Improvement of Colonoscopy Preparation by Using a SPA
Official title: Evaluation of Improvement of Colonoscopy Preparation by Using a SPA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy Preparation
Keywords: Colonoscopy
preparation
new media
SPA
APP
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no smartphone
* \>ASA 3 (no possibility for outpatient colonoscopy)

Primary outcomes:
measure: Quality of Bowel preparation
timeFrame: During colonoscopy procedure
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: histological analysis after colonoscopy up to 10 days (d10)
measure: Acceptance of patients towards bowel preparation procedure
timeFrame: at colonoscopy appointment (day 0)
Other outcomes:
Locations:
city: Dornstadt
country: Germany
facility: Gastroenterologische Praxis Dornstadt
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Ludwigsburg
country: Germany
facility: Krankenhaus Ludwigsburg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Universitätsklinikum Ulm
name: Benjamin M Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30.