Alimentary pharmacology & therapeutics · 2025
Clinical Trial: Simplified Bowel Preparation for Small Bowel Capsule Endoscopy in Crohn's Disease.
Equivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rouveyre Raphaëlle, Coudol Sandrine, Collins Michael, de Maissin Astrid, Flamant Mathurin, Trang Caroline, Freyssinet Marie, Bouguen Guillaume, Dib Nina, Bourreille Arnaud, Le Berre Catherine
Аннотация
BACKGROUND: Small bowel (SB) capsule endoscopy (SBCE) is a key tool in patients with Crohn's disease (CD). Optimal bowel preparation remains debated.
AIMS: To compare the efficacy of a simplified preparation (clear liquid diet with 500 mL of water pre- and 1 L post-capsule ingestion) to a polyethylene glycol (PEG)-based preparation (24 h-residue-free diet with 2 L of PEG) in patients with established CD.
METHODS: In this randomised, controlled, single-blind, superiority, multicentre trial, patients were assigned 1:1 to either the simplified preparation or the PEG-based preparation. Intestinal cleanliness (quantified by the KODA score and qualitatively evaluated), patient acceptability, diagnostic yield, capsule completion rate, and SB transit time (SBTT) were compared between groups.
RESULTS: With 142 SBCE, we observed no difference in intestinal cleanliness. Patients' acceptability of preparation and SBCE procedure was significantly higher with the simplified preparation. Diagnostic yield was similar, as well as the capsule completion rate and SBTT. The area under the receiver operating characteristic curve of the KODA score was 0.87 (95% CI: 0.84-0.90). Using a threshold of 2.25, the score allowed us to discriminate images with 'good' and 'fair or poor' cleanliness with accuracy, sensitivity, and specificity of 80%, 76%, and 84%, respectively.
CONCLUSIONS: A simplified preparation consisting of a clear liquid diet and water is a viable alternative to a PEG-based preparation prior to SBCE in patients with CD, offering comparable SB cleanliness and diagnostic outcomes while improving acceptability.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05117996 and the article was written in line with the Consolidated Standards of Reporting Trials (CONSORT) checklist.
AIMS: To compare the efficacy of a simplified preparation (clear liquid diet with 500 mL of water pre- and 1 L post-capsule ingestion) to a polyethylene glycol (PEG)-based preparation (24 h-residue-free diet with 2 L of PEG) in patients with established CD.
METHODS: In this randomised, controlled, single-blind, superiority, multicentre trial, patients were assigned 1:1 to either the simplified preparation or the PEG-based preparation. Intestinal cleanliness (quantified by the KODA score and qualitatively evaluated), patient acceptability, diagnostic yield, capsule completion rate, and SB transit time (SBTT) were compared between groups.
RESULTS: With 142 SBCE, we observed no difference in intestinal cleanliness. Patients' acceptability of preparation and SBCE procedure was significantly higher with the simplified preparation. Diagnostic yield was similar, as well as the capsule completion rate and SBTT. The area under the receiver operating characteristic curve of the KODA score was 0.87 (95% CI: 0.84-0.90). Using a threshold of 2.25, the score allowed us to discriminate images with 'good' and 'fair or poor' cleanliness with accuracy, sensitivity, and specificity of 80%, 76%, and 84%, respectively.
CONCLUSIONS: A simplified preparation consisting of a clear liquid diet and water is a viable alternative to a PEG-based preparation prior to SBCE in patients with CD, offering comparable SB cleanliness and diagnostic outcomes while improving acceptability.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05117996 and the article was written in line with the Consolidated Standards of Reporting Trials (CONSORT) checklist.