NCT05726097

Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colon Cancer
• Inflammatory Bowel Diseases
• Gastrointestinal Bleed
• Colon Polyp

Interventions

Type	Name	Description
DRUG	polyethylene glycol	colonic preparation
DRUG	sodium phosphate	colonic preparation
DRUG	polyethylene glycol + ascorbic acid	colonic preparation
DRUG	gastrografin	colonic preparation
DRUG	magnesiumoxid + sodium picosulfate	colonic preparation
DRUG	prucalopride	colonic preparation

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2023-02-13
• Last updated: 2024-02-28

Locations

1 site across 1 country: Sweden