QR Code for Endoscopic Bowel Preparation

Status Recruiting

Clinical Trial Summary

Patients presenting for colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. Before inclusion, all patients have to sign the written informed consent. All participating patients will receive PLENVU, a well-known and approved bowel preparation agent. Patients are randomly assigned in two groups. Patients in group 1 are informed in traditional way on how to use the bowel preparation agent. This way includes discussion with the physician and nurse on how to use the bowel preparation agent and a written documentation, highlighting the individual steps again. Patients in group 2 will receive in addition a QR-code referring to an App, available for free in all App stores, explaining to the patient in detail when and how to use the bowel preparation agent. The patient is receiving the same questionnaire (please see attached) in both groups and asked to bring the filled form on the day of the examination. Endoscopy is performed in standard way and effectiveness of the bowel preparation is specifically highlighted by the physician on the documentation report. Finally, data is analyzed regarding effectiveness of the QR code regarding patient satisfaction, acceptability and quality of the bowel preparation.

Clinical Trial Description

Patient education is of paramount importance for high acceptance and an adequate bowel preparation. Using the QR code directly referring to the App for bowel preparation with PLENVU might accelerate the discussion between the medical doctor and the patient and might also improve the acceptance rate of the patients for the bowel preparation finally leading to a more enhanced and effective bowel-preparation.

Patients undergoing screening or surveillance endoscopy will be prospectively included and randomly assigned to one of the following groups: Group 1: App; Group 2: no-App Study end points addressed below are prospectively assessed and evaluated for any significant changes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04456231
Study type	Observational
Source	Johannes Gutenberg University Mainz
Contact	Helmut Neumann, Prof. Dr.
Phone	+4917866516595
Email	helmut.neumann@unimedizin-mainz.de
Status	Recruiting
Phase
Start date	September 2020
Completion date	June 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.