Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard preparation regimen 4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster |
Drug: polyethylene glycol
colonic preparation
Other Names:
Drug: sodium phosphate
colonic preparation
Other Names:
|
| Experimental: Optimized preparation regimen 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster |
Drug: polyethylene glycol + ascorbic acid
colonic preparation
Other Names:
Drug: gastrografin
colonic preparation
Drug: magnesiumoxid + sodium picosulfate
colonic preparation
Other Names:
|
| Experimental: Optimized preparation regimen with prucalopride 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride |
Drug: polyethylene glycol + ascorbic acid
colonic preparation
Other Names:
Drug: gastrografin
colonic preparation
Drug: magnesiumoxid + sodium picosulfate
colonic preparation
Other Names:
Drug: prucalopride
colonic preparation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Completeness rate [Within 3 months after completed capsule colonoscopy]
Visualization of the hemorrhoidal plexus or an excreted capsule
- Adequate cleanliness rate [Within 3 months after completed capsule colonoscopy]
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale
Secondary Outcome Measures
- Transit times [Within 3 months after completed capsule colonoscopy]
Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations
- Diagnostic yield [Within 3 months after completed capsule colonoscopy]
Findings in the small and large bowel
- Assessment of patient tolerance of the bowel preparations [Within 3 months after completed capsule colonoscopy]
Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skåne University Hospital | Malmö | Sweden | 20502 |
Sponsors and Collaborators
- Region Skane
- Lund University
- Odense University Hospital
Investigators
- Principal Investigator: Ervin Toth, MD PhD, Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden
Study Documents (Full-Text)
More Information
Publications
None provided.- 2022-06303-02