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Study Comparing Bowel Cleansing Agents Plenvu and Picoprep for Patients Undergoing Colonoscopy to Exclude Colorectal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on comparing two bowel cleansing agents, Plenvu and Picoprep, which are used before a colonoscopy. A colonoscopy is a procedure that allows doctors to examine the inside of the large bowel using a fiberoptic device. The purpose of this study is to determine how effective and tolerable these two cleansing agents are when preparing the bowel for this examination. The patients involved in this study are those who are being checked to rule out colorectal cancer. The cleansing process is important because it helps improve the visibility of the bowel lining, which is crucial for the quality of the colonoscopy.

Plenvu is a relatively new bowel preparation that contains substances like ascorbic acid (also known as Vitamin C), sodium ascorbate, potassium chloride, sodium chloride, and macrogol 3350. It is a low-volume solution that is taken orally. On the other hand, Picoprep is a well-established preparation that includes sodium picosulfate, magnesium oxide, and citric acid. This study aims to see if Plenvu is as effective as Picoprep in cleaning the bowel and if it is easier for patients to tolerate.

Participants in the study will be randomly assigned to receive either Plenvu or Picoprep before their colonoscopy. The study will monitor how well each agent cleans the bowel and how patients feel about taking them. The trial will help determine if Plenvu can provide a similar or better experience compared to Picoprep in terms of both effectiveness and patient comfort.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is informed about the trial's objective, which is to compare the effectiveness and comfort of two bowel cleansing agents, Plenvu and Picoprep, before a colonoscopy.
The patient must be over 18 years old and scheduled for an outpatient colonoscopy to participate.
Step 2
Medication assignment
The patient is randomly assigned to receive either Plenvu or Picoprep as the bowel cleansing agent.
Plenvu is a low-volume solution containing ascorbic acid, sodium ascorbate, potassium chloride, sodium chloride, and macrogol 3350.
Picoprep contains sodium picosulfate, magnesium oxide, and citric acid.
Step 3
Medication administration
The patient is instructed to take the assigned medication orally as an oral solution.
The specific dosage and frequency are provided by the study team, ensuring the patient follows the instructions for effective bowel cleansing.
Step 4
Colonoscopy procedure
After completing the bowel cleansing process, the patient undergoes a colonoscopy, which is an examination of the large bowel using a fiberoptic device.
The quality of the bowel cleansing is assessed during this procedure to determine the effectiveness of the assigned medication.
Step 5
Evaluation of tolerability
The patient provides feedback on the comfort and any side effects experienced during the bowel preparation process.
This information helps evaluate the tolerability of Plenvu compared to Picoprep.
Step 6
Completion of participation
The patient's participation in the trial concludes after the colonoscopy and feedback process.
The study aims to determine if Plenvu is as effective and comfortable as Picoprep for bowel preparation.

Who can join the trial?

4 criteria

The patient must be scheduled for an ambulant colonoscopy. This means the procedure is done on an outpatient basis, and the patient does not need to stay overnight in the hospital.
The patient must be older than 18 years of age.
Both male and female patients are eligible to participate.
The study does not include vulnerable populations, which typically refers to groups that may need special protection or care.

Who cannot join the trial?

10 criteria

Patients who are not referred for a colonoscopy to check for colorectal cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
Patients who have any medical condition that might interfere with the study or the safety of the patient cannot participate.
Patients who are unable to follow the study procedures or instructions cannot participate.
Patients who have allergies or reactions to the ingredients in the bowel cleansing agents being tested cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had recent surgery or medical procedures that might affect the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of certain digestive system diseases that might affect the study cannot participate.

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Aalborg University Hospital
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Aalborg, Denmark

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Investigated drugs

Plenvu
is a bowel cleansing agent used before a colonoscopy. It is a relatively new preparation that helps clear the intestines by causing bowel movements. The goal of using Plenvu is to ensure the colon is clean so that the doctor can get a clear view during the colonoscopy. It is designed to be effective while being easier to tolerate, as it requires a lower volume of liquid to be consumed compared to some other preparations.
Picoprep
is a well-established bowel preparation used before a colonoscopy. It works by causing the intestines to empty, which helps in cleaning the colon. Picoprep is based on picosulfate, which is a type of laxative. It has been used for many years and is known for its effectiveness in preparing the bowel for examination. The trial aims to compare its efficacy and tolerability with that of Plenvu.

What is already known about the treatment

Plenvu
Plenvu is a bowel cleansing agent administered orally in preparation for a colonoscopy. It is a relatively new product in the medical field, designed to improve the visualization of the bowel mucosa during the procedure. The main therapeutic indication for Plenvu is bowel cleansing prior to a colonoscopy. It works by using a low-volume polyethylene glycol-electrolyte solution to induce bowel movements, effectively clearing the bowel. Plenvu is classified as a laxative, specifically a bowel preparation agent.
Picoprep
Picoprep is an established bowel cleansing agent taken orally before a colonoscopy. It is widely recognized in medical literature for its effectiveness in preparing the bowel for examination. The primary use of Picoprep is to cleanse the bowel, ensuring clear visibility of the mucosa during a colonoscopy. It functions by utilizing sodium picosulfate, which stimulates bowel movements, aiding in the removal of bowel contents. Picoprep falls under the pharmacological classification of laxatives, specifically bowel preparation agents.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease may not cause symptoms initially, but as it progresses, it can lead to changes in bowel habits, blood in the stool, and abdominal discomfort. Early detection through screening methods like colonoscopy can help identify and remove polyps before they turn into cancer. The progression of colorectal cancer can vary, with some cases advancing more rapidly than others.