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Recruiting
NCT05700981
Colon Capsule Endoscopy in Patients With Colonic Diverticulitis
Conditions: Diverticulitis, Colonic
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Odense University Hospital
Location: Denmark
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.
Our 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: We 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.
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.
Eligibility Criteria
Inclusion Criteria:Patients above the age of 18 with in-hospital CT-diagnosed diverticulitisExclusion Criteria: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 pacemakerRenal insufficiencyPregnancy/breastfeedingAllergies towards active substances administered in the trialUnable to provide oral and written informed consent
Source: ClinicalTrials.gov (NCT05700981). StuddyBuddy aggregates publicly available trial information.