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Colon Capsule Endoscopy in Patients With Colonic Diverticulitis

NCT05700981 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Diverticulitis, Colonic

Interventions

DIAGNOSTIC_TEST

colon capsule endoscopy

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Thomas Bjørsum-Meyer, M.D., PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05700981 on ClinicalTrials.gov