Colon Capsule Endoscopy in Patients With Colonic Diverticulitis
CACODI
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 11, 2023
January 1, 2023
11 months
January 17, 2023
September 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient discomfort and preference
These patient-reported outcomes as well as an evaluation on patient preferences will be investigated using questionnaires
6 months
Secondary Outcomes (2)
Re-investigation rate
6 months
Number of neoplastic lesions
6 months
Study Arms (2)
Colon capsule endoscopy
EXPERIMENTALPatients randomized to colon capsule endoscopy
Colonoscopy
NO INTERVENTIONPatients randomized to colonoscopy
Interventions
Patient allocated for the intervention arm will have a CCE using the PillCam Colon 2 (Medtronic, Minneapolis, Minnesota, USA). Upon inclusion and allocation to the intervention arm patients are contacted by a dedicated CCE nurse. The course of the CCE procedure and preparations are explained thoroughly. In case of additional questions patients can contact the nurses by telephone during office hours (Monday-Friday, 8am-3pm). Before the CCE participants will have to undergo a bowel preparation procedure. The bowel preparation kit will be distributed by mail and is to be completed at home, beginning 72 hours before the CCE. The kit contains polyethylene glycol (PEG) sachets (Movicol, Norgine Danmark A/S, Herlev, Denmark), PEG solutions (MoviPrep, Norgine Danmark A/S, Herlev Denmark) and instructions on how to properly perform the preparation procedures.
Eligibility Criteria
You may qualify if:
- Patients above the age of 18 with in-hospital CT-diagnosed diverticulitis
You may not qualify if:
- Recent imaging of the colonic mucosa and therefore no indication for renewed endoscopy, evaluated by the attending physician.
- Colonic CT findings that require biopsy (suspected cancer) or polyp removal.
- CT-verified stenosis in the gastrointestinal (GI) tract.
- Cardiac pacemaker
- Renal insufficiency
- Pregnancy/breastfeeding
- Allergies towards active substances administered in the trial
- Unable to provide oral and written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, Funen, 5000, Denmark
Related Publications (1)
Schelde-Olesen B, Kaalby L, Deding U, Thygesen MMI, Andersen PV, Koulaouzidis A, Baatrup G, Bjorsum-Meyer T. 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.
PMID: 37802611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Bjørsum-Meyer, M.D., PhD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
January 26, 2023
Study Start
February 1, 2023
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
September 11, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1/1-2023 - 31/12-2023
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
Relevant anonymized data are available upon reasonable request. Data requesters should do the following to obtain data: Email the corresponding author for the paper to request the relevant data.