QR Code for Endoscopic Bowel Preparation

NCT ID: NCT04456231

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 404 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-06-30

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Plenvu

Intervention Type: DRUG

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.

Plenvu

Intervention Type: DRUG

Patients will receive Plenvu for preparation of endoscopy

Interventions

Plenvu

Patients will receive Plenvu for preparation of endoscopy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Prof. Helmut Neumann

University Professor Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helmut Neumann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz

Locations

Dr. Helmut Neumann

Bad Salzuflen, Northrine-Westfalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Helmut Neumann, Prof. Dr.

Role: CONTACT

helmut.neumann@unimedizin-mainz.de

+4917866516595

Tanja Bender, M.A.

Role: CONTACT

tanja.bender@unimedizin-mainz.de

+496131 ext. 176838

Facility Contacts

Helmut Neumann, Dr. med.

Role: primary

+495222 ext. 369836

Other Identifiers

126

Identifier Type: -

Identifier Source: org_study_id