QR Code for Endoscopic Bowel Preparation

NCT04456231 | Unknown DMC

• 1 other identifier: 126
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of patients who are satisfied with preparation

  up to 1 month

• Number of patients who Accept to repeat the examination (surveillance)

  up to 1 month

• cecal intubation rate

  1 day

• procedure time

  3 hours

Study Arms (2)

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

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

Interventions

Plenvu DRUG

Patients will receive Plenvu for preparation of endoscopy

QR Code; no QR Code

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Screening or surveillance colonoscopy
• Age 18-85 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Dr. Helmut Neumann

Bad Salzuflen, Northrine-Westfalia, 32105, Germany

RECRUITING

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Helmut Neumann, Prof. Dr.

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helmut Neumann, Prof. Dr.

CONTACT

+4917866516595; helmut.neumann@unimedizin-mainz.de

Tanja Bender, M.A.

CONTACT

+496131; tanja.bender@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor Dr. med.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 2, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: First Data: January 2021 full Data: December 2021
• Access Criteria: Abstracts and Publication

Locations

DE (1)