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Research Article: Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial)

Date Published: 2023-10-06

Abstract:
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 .

Introduction:
Colonic diverticulosis is a common condition with a prevalence that increases significantly with age. 1 It has been suggested that more than two-thirds of the adult population will eventually develop colonic diverticulosis. 2 The condition is often found incidentally during colonoscopy or CT, as only 20% of patients with colonic diverticulosis present with symptoms. A study found that approximately 4% of patients experienced progression from colonic diverticulosis to diverticulitis, but only 1% had the diagnosis…

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