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

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. 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. 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. NCT05700981.

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Déclaration de conflit d'intérêts

Competing interests: TB-M has received grants from the Region of Southern Denmark and the Centre of Clinical Implementation for Capsule Endoscopy (CICA). TB-M is member of an Advisory Board for Medtronic regarding optimising bowel preparation in colon capsule endoscopy. Anastasios Koulaouzidis is codirector and shareholder of iCERV Ltd. He has received consultancy fees and travel support from Jinshan Ltd, Diagmed Healthcare Ltd and research support (grant) from ESGE/Given Imaging Ltd and IntroMedic/SynMed, honoraria from Jinshan and Medtronic and has participated in advisory board meetings hosted by ANKON.