Clinical trial NCT05726097: Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
Official title: Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer
Inflammatory Bowel Diseases
Gastrointestinal Bleed
Colon Polyp
Keywords: colon capsule endoscopy
panenteric capsule endoscopy
colon preparation
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Odense University Hospital
First posted: 2023-02-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Completeness rate
timeFrame: Within 3 months after completed capsule colonoscopy
measure: Adequate cleanliness rate
timeFrame: Within 3 months after completed capsule colonoscopy
Secondary outcomes:
measure: Transit times
timeFrame: Within 3 months after completed capsule colonoscopy
measure: Diagnostic yield
timeFrame: Within 3 months after completed capsule colonoscopy
measure: Assessment of patient tolerance of the bowel preparations
timeFrame: Within 3 months after completed capsule colonoscopy
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden
name: Ervin Toth, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: