Clinical trial NCT04457934: Effectiveness of PLENVU in the General Screening Population and Patients With IBD
Official title: Effectiveness of PLENVU in the General Screening Population and Patients With IBD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IBD
Healthy
Keywords: endoscopy
preparation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Screening colonoscopy; IBD; age group 18-75 years

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Boston Bowel Preparation Standard (BBPS)
timeFrame: 1 week
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 day
measure: Number of patients with adverse events
timeFrame: up to 1 week
Secondary outcomes:
measure: Number of patients who are willing to accept repeated examination (surveillance);
timeFrame: up to 1 month
measure: Adenoma and Polyp Detection Rate (ADR and PDR)
timeFrame: 1 day
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
city: Koblenz
country: Germany
facility: Dr. Horst Hohn
state: Rhenanie-Palatinate
city: Mainz
country: Germany
facility: University Hospital Mainz
Study officials:
affiliation: University Medical Center Mainz
name: Helmut Neumann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: