Quality Standards in ColonoscopyNCT04456231
QR Code for Endoscopic Bowel Preparation
An observational study of Quality Standards in Colonoscopy and Patient Education, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality Standards in Colonoscopy, Patient Education, Acceptance of Bowel-preparation
- What is being tested?
- Plenvu
- How many people
- 404 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- • Screening or surveillance colonoscopy
- Age 18-85 years
- Written informed consent
Who cannot join
- • Pregnancy or lactating
- Lower gastrointestinal bleeding with hemodynamic instability
- Bowel obstruction
- ASA >3
- Not sufficiently corrected anticoagulation disorders
- Plenvu must not be taken:
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dr. Helmut Neumann
Bad Salzuflen, Northrine-Westfalia, 32105
Helmut Neumann, Dr. med., +495222 ext. 369836
About this study
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
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.
Read the 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.
- Being tested
- Plenvu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlenvuDrug
Patients will receive Plenvu for preparation of endoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Plenvu |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 1 day
Adenoma detection rate (ADR)
How many adenomas will be detected during endoscopy
Measured: 1 day
Polyp detection rate (PDR)
How many polyps will be detected during endoscopy
Measured: 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
Measured: 1 day
Secondary outcomes (4)
Number of patients who are satisfied with preparation
How will doctors and patients like preparation with Plenvu and QR Code
Measured: up to 1 month
Number of patients who Accept to repeat the examination (surveillance)
How many patients will come back for another endoscopy
Measured: up to 1 month
cecal intubation rate
How many endoscopies will reach the ceacum
Measured: 1 day
procedure time
How Long will endoscopy take compared to Standard technique
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality Standards in ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Helmut Neumann, Johannes Gutenberg University Mainz
- Investigators
- Helmut Neumann, Prof. Dr., Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456231
- Sponsor's protocol ID
- 126
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04456231
- Acronym / sponsor ID
- 126
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QR Code | – | Drug: PlenvuPatients 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. |
| no QR Code | – | Drug: PlenvuPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- • Screening or surveillance colonoscopy
Key exclusion criteria (23 listed)
- • Pregnancy or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlenvuPatients will receive Plenvu for preparation of endoscopy | Drug | QR Code, no QR Code |
Primary outcome
Boston Bowel Preparation Standard (BBPS)
Time frame: 1 day
Bowel preparation according to international Standard, 1 is bad, 9 is very good, how many patients can Achieve BBPS with 9?
Adenoma detection rate (ADR)
Time frame: 1 day
How many adenomas will be detected during endoscopy
Polyp detection rate (PDR)
Time frame: 1 day
How many polyps will be detected during endoscopy
time exposure to explain bowel preparation
Time frame: 1 day
How much time will patients Need for preparation and how much time for discussing with the doctors
4 secondary outcomes
Number of patients who are satisfied with preparation
Time frame: up to 1 month
Number of patients who Accept to repeat the examination (surveillance)
Time frame: up to 1 month
cecal intubation rate
Time frame: 1 day
procedure time
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Neumann, Prof. Dr. principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality Standards in Colonoscopy and Patient Education, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helmut Neumann, Prof. Dr. (+4917866516595, helmut.neumann@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Standard (BBPS) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.