QR Code for Endoscopic Bowel Preparation

Patient Education Clinical Trial

Official title:

Effect of the Additional Use of a QR Code for More Effective Patient Education and High-quality Bowel Preparation in the Outpatient Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456231
• Other study ID #: 126
• Status: Recruiting
• Start date: September 2020
• Est. completion date: June 2021

Study information

• Verified date: September 2020
• Source: Johannes Gutenberg University Mainz
• Contact: Helmut Neumann, Prof. Dr.
• Phone: +4917866516595
• Email: helmut.neumann[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: June 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• • Screening or surveillance colonoscopy

• Age 18-85 years

• Written informed consent

Exclusion Criteria:

• • Pregnancy or lactating

• Lower gastrointestinal bleeding with hemodynamic instability

• Bowel obstruction

• ASA >3

• Not sufficiently corrected anticoagulation disorders

• Plenvu must not be taken:

• if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medicine;

• if you have a blockage (obstruction) in the digestive tract.

• if you have a breakthrough (perforation) in the wall of the digestive tract;

• if you suffer from intestinal obstruction (Ileus);

• if you suffer from a disturbance of gastric emptying (e.g. gastroparesis, gastric retention);

• if you suffer from phenylketonuria. Phenylketonuria is a congenital metabolic disease in which phenylalanine cannot be processed by your body. Plenvu contains aspartame as a source of phenylalanine;

• if you suffer from glucose-6-phosphate dehydrogenase deficiency;

• if you suffer from acute colon enlargement (toxic megacolon).

• Warnings and precautions

o You should tell your doctor about the following circumstances before taking Plenvu:

• if you have heart problems and/or arrhythmias;

• if you have kidney problems and/or suffer from dehydration;

• if you have stomach or intestinal problems, including intestinal inflammation;

• if you have difficulty or discomfort when swallowing liquids;

• if you have high or low levels of electrolyte (e.g. sodium, potassium);

• if you have other diseases (e.g. convulsions).

• Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy or lactation and is therefore not recommended.

Related Conditions & MeSH terms

• Acceptance of Bowel-preparation
• Patient Education
• Quality Standards in Colonoscopy

Intervention

Drug:
• Plenvu
Patients will receive Plenvu for preparation of endoscopy

Locations

Country	Name	City	State
Germany	Dr. Helmut Neumann	Bad Salzuflen	Northrine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Standard (BBPS)	Bowel preparation according to international Standard, 1 is bad, 9 is very good, how many patients can Achieve BBPS with 9?	1 day
Primary	Adenoma detection rate (ADR)	How many adenomas will be detected during endoscopy	1 day
Primary	Polyp detection rate (PDR)	How many polyps will be detected during endoscopy	1 day
Primary	time exposure to explain bowel preparation	How much time will patients Need for preparation and how much time for discussing with the doctors	1 day
Secondary	Number of patients who are satisfied with preparation	How will doctors and patients like preparation with Plenvu and QR Code	up to 1 month
Secondary	Number of patients who Accept to repeat the examination (surveillance)	How many patients will come back for another endoscopy	up to 1 month
Secondary	cecal intubation rate	How many endoscopies will reach the ceacum	1 day
Secondary	procedure time	How Long will endoscopy take compared to Standard technique	3 hours