Colon Cancer, Inflammatory Bowel Diseases, Gastrointestinal Bleed, Colon Polyp
Conditions
Keywords
colon capsule endoscopy, panenteric capsule endoscopy, colon preparation
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.
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.
Interventions
DRUGpolyethylene glycol
colonic preparation
DRUGsodium phosphate
colonic preparation
DRUGpolyethylene glycol + ascorbic acid
colonic preparation
DRUGgastrografin
colonic preparation
DRUGmagnesiumoxid + sodium picosulfate
colonic preparation
DRUGprucalopride
colonic preparation
Sponsors
Lund University
Odense University Hospital
Region Skane
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed