QR Code for Endoscopic Bowel Preparation

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

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.

Study Overview

• Status: Unknown
• Conditions: Patient Education; Quality Standards in Colonoscopy; Acceptance of Bowel-preparation
• Intervention / Treatment: Drug: Plenvu

Detailed 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 Type: Observational
• Enrollment (Anticipated): 404

Contacts and Locations

• Study Contact: Name: Helmut Neumann, Prof. Dr.; Phone Number: +4917866516595; Email: helmut.neumann@unimedizin-mainz.de
• Study Contact Backup: Name: Tanja Bender, M.A.; Phone Number: 176838 +496131; Email: tanja.bender@unimedizin-mainz.de

Study Locations

• Germany
  • Northrine-Westfalia
    • Bad Salzuflen, Northrine-Westfalia, Germany, 32105
      • Recruiting
      • Dr. Helmut Neumann
      • Contact: Helmut Neumann, Dr. med.; Phone Number: 369836 +495222

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Group 1: patients receiving traditional information how to prepare the colon Group 2: patients receiving 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QR Code; Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. In Addition, this Group will receive a health app for better preparation and more Information regarding preparation and endoscopy itself.	Drug: Plenvu; Patients will receive Plenvu for preparation of endoscopy
no QR Code; Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. This Group will have no app and will have to receive Information in traditional ways.	Drug: Plenvu; Patients will receive Plenvu for preparation of endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adenoma detection rate (ADR)	How many adenomas will be detected during endoscopy	1 day
Polyp detection rate (PDR)	How many polyps will be detected during endoscopy	1 day
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who are satisfied with preparation	How will doctors and patients like preparation with Plenvu and QR Code	up to 1 month
Number of patients who Accept to repeat the examination (surveillance)	How many patients will come back for another endoscopy	up to 1 month
cecal intubation rate	How many endoscopies will reach the ceacum	1 day
procedure time	How Long will endoscopy take compared to Standard technique	3 hours

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Helmut Neumann, Prof. Dr., University Medical Center Mainz

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Preliminary results for DDW (Deadline Dec, 1st, 2020) .

Publication date:

• Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia).
• Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW
• Final manuscript: Gut -> Am J Gastro -> Endoscopy

• IPD Sharing Time Frame: First Data: January 2021 full Data: December 2021
• IPD Sharing Access Criteria: Abstracts and Publication
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No