Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Region Skane

Status and phase: Completed; Phase 3

Conditions: Colon Cancer; Colon Polyp; Gastrointestinal Bleed; Inflammatory Bowel Diseases

Treatments: Drug: gastrografin; Drug: sodium phosphate; Drug: magnesiumoxid + sodium picosulfate; Drug: prucalopride; Drug: polyethylene glycol + ascorbic acid; Drug: polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT05726097

2022-06303-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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147 participants in 3 patient groups

Standard preparation regimen

Active Comparator group

Description:

4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster

Treatment:

Drug: polyethylene glycol

Drug: sodium phosphate

Optimized preparation regimen

Experimental group

Description:

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster

Treatment:

Drug: polyethylene glycol + ascorbic acid

Drug: magnesiumoxid + sodium picosulfate

Drug: gastrografin

Optimized preparation regimen with prucalopride

Experimental group

Description:

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride

Treatment:

Drug: polyethylene glycol + ascorbic acid

Drug: prucalopride

Drug: magnesiumoxid + sodium picosulfate

Drug: gastrografin