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Published on: August 1, 2019
Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study
Benedicte Schelde-Olesen1,2, Lasse Kaalby3,2, Ulrik Deding3,2
1Department of Clinical Research, University of Southern Denmark, Odense, Denmark benedicte.schelde-olesen@rsyd.dk.
Introduction:
Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. Our objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared with colonoscopy, particularly regarding patient satisfaction and clinical performance.
Methods And Analysis:
We will conduct a single-centre prospective randomised controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomised to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9 mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. We will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.
Ethics And Dissemination:
Informed consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee (ref. S-20210127) and the Danish Data Protection Agency (ref. 22/43235). After completion of the trial, we plan to publish two articles in high-impact journals. One article on both primary and secondary outcomes.
Trial Registration Number:
NCT05700981.
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