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4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride

polyethylene glycol

sodium phosphate

polyethylene glycol + ascorbic acid

gastrografin

magnesiumoxid + sodium picosulfate

prucalopride

Ervin Toth, MD PhD

The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.

Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.

This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.

All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.

The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.

Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Visualization of the hemorrhoidal plexus or an excreted capsule

Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale

Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations

Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects

Lund University

Odense University Hospital

Region Skane

Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Pharmaceutical Solutions

Polyethylene glycol 3350

Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

Sodium Phosphate solution (NaP)

Christian Ell, Prof Dr med

To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies

This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.

Norgine

Hans-Jürgen Gruss

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure	NCT05726097	Colon Cancer Inflammatory Bo... Gastrointestina... Colon Polyp	polyethylene gl... sodium phosphat... polyethylene gl... gastrografin magnesiumoxid +... prucalopride	18 Years -	Region Skane
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening	NCT00427089	Colonoscopy	Macrogol 3350 N... Sodium Phosphat...	18 Years - 85 Years	Norgine
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening	NCT00427089	Colonoscopy	Macrogol 3350 N... Sodium Phosphat...	18 Years - 85 Years	Norgine

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