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

Sep 24, 2026

Uploaded by Stanford

Follow-up after colonic diverticulitis is a common indication for colonoscopy despite evidence of low positive findings. This protocol investigates colon capsule endoscopy (CCE) as a follow-up option versus conventional colonoscopy, focusing on patient satisfaction and clinical performance. A single-centre prospective randomized trial will include CT-confirmed acute diverticulitis patients randomized to colonoscopy or CCE, with diagnostic colonoscopy triggered by suspected cancer, more than two polyps, or any CCE polyp >9 mm.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages6

Reading Time15 min

AccessFree to download

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Strengths and limitations

Open access Protocol Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) Benedicte Schelde-Olesen ,1,2 Lasse Kaalby,1,2 Ulrik Deding ,1,2 Maja M I Thygesen,2 Per Vadgaard Andersen,1,2 Anastasios Koulaouzidis,1,3 Gunnar Baatrup,1,2 Thomas Bjørsum-Meyer1,2 To cite: Schelde-Olesen B, Kaalby L, Deding U, et al. 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;13:e073575 . doi:10 . 1136/ bmjopen-2023-073575 ► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ([http://dx.doi.org/10.1136/](http://dx.doi.org/10.1136/)[ ](http://dx.doi.org/10.1136/)[bmjopen-2023-073575](bmjopen-2023-073575)) . Received 09 March 2023 Accepted 13 September 2023 © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 1Department of Clinical Research, University of Southern Denmark, Odense, Denmark 2Department of Surgery, Odense University Hospital, Odense, Denmark 3Department of Medicine, Odense University Hospital, Odense, Denmark Correspondence to Dr Benedicte Schelde-Olesen; benedicte.schelde-olesen@ [rsyd.dk](rsyd.dk) ABSTRACT Introduction Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, eventhough studies have shown a low risk of positive findingsin 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% STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ The single centre design. ⇒ Clinical data retrieved from patient charts can be of varying quality. ⇒ The implementation of colon capsule endoscopy (CCE) for diverticulitis follow-up within a department that is very familiar with the procedure. ⇒ This is, to our knowledge, the first study investigating CCE as an alternative modality for follow-up after acute diverticulitis. of patients experienced progression from colonic diverticulosis to diverticulitis, but only 1% h

FAQs

What is the primary objective of the CACODI trial?

To evaluate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared with colonoscopy, particularly regarding patient satisfaction and clinical performance.

How are participants assigned and what triggers a diagnostic colonoscopy after CCE?

Patients confirmed by CT will be randomized to follow-up by colonoscopy or CCE. Diagnostic colonoscopy for biopsies or polyp removal is invited if CCE shows suspected cancer, more than two polyps, or any polyp larger than 9 mm.

What outcomes will be compared between colonoscopy and CCE?

They will be compared for patient satisfaction and tolerance, number of complete examinations, number of patients referred to subsequent colonoscopy after CCE, and prevalence of diverticula, polyps, cancers, and other abnormal findings.

Sep 24, 2026

Uploaded by Stanford