Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05700981 |
| Other study ID # |
CACODI trial |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Follow-up after colonic diverticulitis is a common indication for colonoscopy,
even though studies have shown a low risk of positive findings in this population. The
objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in
patients with colonic diverticulitis compared to colonoscopy, on patient satisfaction and
clinical performance.
Methods and Analysis: The investigators will conduct a single centre prospective randomized
controlled trial. Patients seen at Odense University Hospital with acute diverticulitis
confirmed by CT will be included and randomized to either follow-up by colonoscopy or CCE.
Detection of suspected cancer, more than two polyps or any number of polyps larger than 9mm
in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal.
The investigators 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.
Description:
Colon diverticulosis (CD) is extremely common and the prevalence seems to increase globally.
The prevalence of CD increases with age and two-thirds of the adult population eventually
develop CD. In the US the prevalence of CD was 32.6 % in patients aged 50-59 years and 71.4%
in patients > 80 years of age. CD is often detected incidentally during optical colonoscopy
(OC) or by computer tomography (CT). In approximately 25 % of patients with CD symptomatic
colon diverticular disease develop typically comprising bloating, abdominal pain and change
in bowel habits. Progression to diverticulitis is estimated to appear in approximately 1%.
Most patients present with uncomplicated diverticulitis and are managed by general
practitioners (GP) with the use of painkillers and oral antibiotics. Complicated
diverticulitis due to perforation can be classified according to Hinchey et al. as a guidance
to surgeon as to how conservative they can be. Hinchey level 1-2 can be managed
conservatively. In the case of Hinchey level 3 and 4 it requires a laparoscopy with
peritoneal lavage or laparotomy with colon resection and stoma formation, respectively. In
patients presenting at the GP with intractable pain or signs of sepsis admission to hospital
services is mandatory. Upon hospitalization, CT is the preferred diagnostic imaging modality
in patients presenting with abdominal pain and suspected diverticulitis. If colonic
diverticulitis is described as the symptoms-eliciting pathology without complications
comprising abscess or bowel perforation patients are typically discharged from hospital with
painkillers and offered an OC within 4-6 weeks, when the inflammation has resolved, to
confirm the diverticulitis diagnosis. Routine OC after an episode of diverticulitis is
recommended by the majority of international guidelines including Danish guidelines on
handling of patients with diverticulitis. Due to a very low risk of malignancy in patients
with diverticulitis the relevance of routine OC has been questioned in a recent review. The
research in Colon Capsule Endoscopy (CCE) has evolved substantially since the introduction in
2006. More studies have reported a diagnostic yield equal to OC also in regard to larger
polyps > 9 mm. In contrast to OC, CCE does not offer the possibility of biopsy or removal
polyp. Hence, the ideal population for CCE needs to have low risk of findings with the need
of endoscopic intervention. CCE is without pain and the risk of complications is extremely
low compared to colonoscopy for which the estimated risk of major bleeding or perforation is
12 per 10,000 patients.
The investigators aimed to evaluate the effect of introducing CCE on patient satisfaction and
discomfort compared to colonoscopy as a follow-up examination in patients with diverticulitis
and the impact of introducing CCE on the need for subsequent colonoscopy.
