Clinical trial NCT04456231: QR Code for Endoscopic Bowel Preparation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality Standards in Colonoscopy
Patient Education
Acceptance of Bowel-preparation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Boston Bowel Preparation Standard (BBPS)
timeFrame: 1 day
measure: Adenoma detection rate (ADR)
timeFrame: 1 day
measure: Polyp detection rate (PDR)
timeFrame: 1 day
measure: time exposure to explain bowel preparation
timeFrame: 1 day
Secondary outcomes:
measure: Number of patients who are satisfied with preparation
timeFrame: up to 1 month
measure: Number of patients who Accept to repeat the examination (surveillance)
timeFrame: up to 1 month
measure: cecal intubation rate
timeFrame: 1 day
measure: procedure time
timeFrame: 3 hours
Other outcomes:
Locations:
city: Bad Salzuflen
country: Germany
facility: Dr. Helmut Neumann
state: Northrine-Westfalia
Study officials:
affiliation: University Medical Center Mainz
name: Helmut Neumann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: