Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colon capsule endoscopy.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Colorectal Polyp. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete. Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
Interventions
- Device Colon capsule endoscopy
Endoscopy performed using PillCam2 camera capsule for oral ingestion
Primary outcome measures
- Complete mucosal visualization combining incomplete investigations [Time frame: 10 years]
Secondary outcome measures (5)
- Completion rate of colon capsule endoscopy [Time frame: 2 years]
- Safety of colon capsule endoscopy [Time frame: 1 year]
- Quality of colon capsule endoscopy [Time frame: 1 year]
- Economic evaluation [Time frame: 1 year]
- Patient preference [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
Exclusion criteria
- Chrohn's disease with symptoms of stenosis and/or pacemaker
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Odense University Hospital — Svendborg
Publications
- Havshoi AV, Deding U, Jensen SS, Andersen PV, Kaalby L, Al-Najami I. Colon capsule endoscopy following incomplete colonoscopy in routine clinical settings. Surg Endosc. 2023 Apr;37(4):2749-2755. doi: 10.1007/s00464-022-09783-w. Epub 2022 Dec 5. PMID 36471059
Identifiers
NCT: NCT04307901 · 20/4408