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

NCT04457934 | Unknown DMC

• 2 other identifiers: 001125
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 3

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.

Conditions

IBD; Healthy

Keywords

endoscopy; preparation

Outcome Measures

Primary Outcomes (3)

• 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

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  How good will patients tolerate endoscopy and preparation

  1 day

• Number of patients with adverse events

  What Kind of adverse Events can happen during this study

  up to 1 week

Secondary Outcomes (4)

• Number of patients who are willing to accept repeated examination (surveillance);

  up to 1 month

• Adenoma and Polyp Detection Rate (ADR and PDR)

  1 day

• cecal intubation rate

  1 day

• procedure time

  3 hours

Study Arms (2)

IBD patients

Patients with IBD will undergo preparation for Standard endoscopy with PLENVU, since it is considered to be less affecting for patients. IBD patients have to undergo endoscopy often and mostly suffer from non-efficient preparation. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and will follow the Guidelines for preparation of endoscopy. The only Change from Standard care is that patients will receive Plenvu instead of Movicol.

Drug: Plenvu

Screening patients

Screening patients will undergo Standard endoscopy to prevent colon Cancer. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and nd will follow the Guidelines for preparation of endoscopy. The only Change from Standard care is that patients will receive Plenvu instead of Movicol.

Drug: Plenvu

Interventions

Plenvu DRUG

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

IBD patients; Screening patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Screening colonoscopy; IBD; age group 18-75 years

You may qualify if:

• Suspicion or history of IBD
• Screening colonoscopy
• Indication for colonoscopy
• Age 18-75 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 (3)

Dr. Helmut Neumann

Bad Salzuflen, Northrine-Westfalia, 32105, Germany

NOT YET RECRUITING

Dr. Horst Hohn

Koblenz, Rhenanie-Palatinate, 56068, Germany

NOT YET RECRUITING

University Hospital Mainz

Mainz, 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.

CONTACT

+491786651595; helmut.neumann@unimedizin-mainz.de

Tanja Bender, M.A.

CONTACT

+49613117; 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: Head of Interdisciplinary Endoscopy

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 7, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: August 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: January 2021-December 2021
• Access Criteria: Abstracts and publications

Locations

DE (3)