Status:
UNKNOWN
QR Code for Endoscopic Bowel Preparation
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Quality Standards in Colonoscopy
Patient Education
Eligibility:
All Genders
18-85 years
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...
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 t...
Eligibility Criteria
Inclusion
- • Screening or surveillance colonoscopy
- Age 18-85 years
- Written informed consent
Exclusion
- • 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT04456231
Start Date
September 1 2020
End Date
June 1 2021
Last Update
September 7 2020
Active Locations (1)
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1
Dr. Helmut Neumann
Bad Salzuflen, Northrine-Westfalia, Germany, 32105