Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Conditions
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Colon Cancer, Inflammatory Bowel Diseases, Gastrointestinal Bleed, Colon Polyp

Intervention / Treatment
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* Drug: polyethylene glycol
* Drug: sodium phosphate
* Drug: polyethylene glycol + ascorbic acid
* Drug: gastrografin
* Drug: magnesiumoxid + sodium picosulfate
* Drug: prucalopride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard preparation regimen<br>4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster | Drug: polyethylene glycol<br>* colonic preparation<br>* Other names: Laxabon;Drug: sodium phosphate<br>* colonic preparation<br>* Other names: Phosphoral;|
| Experimental: Optimized preparation regimen<br>1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster | Drug: polyethylene glycol + ascorbic acid<br>* colonic preparation<br>* Other names: Plenvu;Drug: gastrografin<br>* colonic preparation<br>Drug: magnesiumoxid + sodium picosulfate<br>* colonic preparation<br>* Other names: Picoprep;|
| Experimental: Optimized preparation regimen with prucalopride<br>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<br>* colonic preparation<br>* Other names: Plenvu;Drug: gastrografin<br>* colonic preparation<br>Drug: magnesiumoxid + sodium picosulfate<br>* colonic preparation<br>* Other names: Picoprep;Drug: prucalopride<br>* colonic preparation<br>* Other names: Resolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness rate | Visualization of the hemorrhoidal plexus or an excreted capsule | Within 3 months after completed capsule colonoscopy | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Diagnostic yield | Findings in the small and large bowel | Within 3 months after completed capsule colonoscopy | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon capsule endoscopy, panenteric capsule endoscopy, colon preparation