Effectiveness of PLENVU in the General Screening Population and Patients With IBD

Healthy Clinical Trial

Official title:

Effectiveness of PLENVU in the General Screening Population and Patients With IBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457934
• Other study ID #: 001
• Secondary ID: 125
• Status: Recruiting
• Start date: September 2020
• Est. completion date: August 2021

Study information

• Verified date: September 2020
• Source: Johannes Gutenberg University Mainz
• Contact: Helmut Neumann, Prof.
• Phone: +491786651595
• Email: helmut.neumann[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. The aim is that the final study population will comprise of 50% IBD patients and 50% colorectal cancer screening patients. 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. Bowel preparation is performed following the general recommendations of use. Following the bowel preparation, patients are asked if they have well tolerated the preparation, if they already had a colonoscopy in the past with another bowel preparation agent and if they would prefer PLENVU or another bowel preparation for their next endoscopy 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 PLENVU for bowel preparation and patient satisfaction.

Description:

PLENVU is effective for bowel preparation and the efficacy and safety of PLENVU has been investigated in randomized controlled trials in patients undergoing gut cleansing prior to colonoscopy. Data on the specific screening population and for patients suffering from IBD however is limited to date. The aim of the current study is to fill this gap and to provide data of the effectiveness of PLENVU for the specific patients groups in order to provide specific recommendations for an adequate bowel preparation in those groups.

In general, bowel-preparation in IBD patients is often more challenging. This might be due to the chronic disease burden but also according to compliance factors of individual patients. Of note, an adequate bowel-preparation is of paramount importance in IBD in order to detect subtle neoplasia and to perform chromoendoscopy, which is still recommended by the updated ESGE guideline.

It is anticipated, that PLENVU will help IBD patients to achieve a better bowel preparation, thereby yielding in more effective screening colonoscopies and higher acceptance rates of patients for surveillance colonoscopies. In order to show that no significant differences are seen in the included IBD cohort compared to the general screening population (bias risk), the investigators aim to also include patients from the normal screening population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: August 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• • Suspicion or history of IBD

• Screening colonoscopy

• Indication for colonoscopy

• Age 18-75 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.

Related Conditions & MeSH terms

• Healthy
• IBD

Intervention

Drug:
• Plenvu
All patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines

Locations

Country	Name	City	State
Germany	Dr. Helmut Neumann	Bad Salzuflen	Northrine-Westfalia
Germany	Dr. Horst Hohn	Koblenz	Rhenanie-Palatinate
Germany	University Hospital Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Standard (BBPS)	Bowel preparation according to international Standard (1 is bad, 9 is good), how many BBPs with 9 can be achieved?	1 week
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	How good will patients tolerate endoscopy and preparation	1 day
Primary	Number of patients with adverse events	What Kind of adverse Events can happen during this study	up to 1 week
Secondary	Number of patients who are willing to accept repeated examination (surveillance);	How many patients will come back for another endoscopy	up to 1 month
Secondary	Adenoma and Polyp Detection Rate (ADR and PDR)	How many adenomas and polyps are detected during endoscopy	1 day
Secondary	cecal intubation rate	how many endoscopies will reach the ceacum	1 day
Secondary	procedure time	how Long will endoscopy take	3 hours