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

BMJ Open. 2023 Oct 6;13(10):e073575. doi: 10.1136/bmjopen-2023-073575.

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.

Keywords: Clinical Trial; Diagnostic Imaging; Endoscopy; Patient Reported Outcome Measures.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Capsule Endoscopy*
  • Colonic Polyps* / diagnosis
  • Colonic Polyps* / pathology
  • Colonoscopy / methods
  • Colorectal Neoplasms* / diagnosis
  • Diverticulitis, Colonic* / diagnostic imaging
  • Equivalence Trials as Topic
  • Humans
  • Prospective Studies
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT05700981