Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Colon Cancer Clinical Trial

Official title:

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05726097
• Other study ID #: 2022-06303-02
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject referred for clinical colon/panenteric examination

• Subject received an explanation about the nature of the study and agreed to provide written informed consent

Exclusion Criteria:

• Subject with dysphagia or any swallowing disorder

• Subject with a prior stomach, small bowel, or colonic resection

• Subject with severe renal insufficiency

• Subject with any allergy or other known contraindication to the medications used in the study

• Women who are either pregnant or nursing

• Subject suffers from life threatening conditions

Related Conditions & MeSH terms

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

Intervention

Drug:
• polyethylene glycol
colonic preparation
• sodium phosphate
colonic preparation
• polyethylene glycol + ascorbic acid
colonic preparation
• gastrografin
colonic preparation
• magnesiumoxid + sodium picosulfate
colonic preparation
• prucalopride
colonic preparation

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Lund University, Odense University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness rate	Visualization of the hemorrhoidal plexus or an excreted capsule	Within 3 months after completed capsule colonoscopy
Primary	Adequate cleanliness rate	Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale	Within 3 months after completed capsule colonoscopy
Secondary	Transit times	Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations	Within 3 months after completed capsule colonoscopy
Secondary	Diagnostic yield	Findings in the small and large bowel	Within 3 months after completed capsule colonoscopy
Secondary	Assessment of patient tolerance of the bowel 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	Within 3 months after completed capsule colonoscopy