Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
SOCRATEC
1 other identifier
observational
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
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
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
May 20, 2020
May 1, 2020
10.4 years
March 12, 2020
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete mucosal visualization combining incomplete investigations
By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.
10 years
Secondary Outcomes (5)
Completion rate of colon capsule endoscopy
2 years
Safety of colon capsule endoscopy
1 year
Quality of colon capsule endoscopy
1 year
Economic evaluation
1 year
Patient preference
2 years
Study Arms (3)
Incomplete colonoscopy
Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.
Colonoscopy general anesthesia
Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.
Colonoscopy declined
Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.
Interventions
Endoscopy performed using PillCam2 camera capsule for oral ingestion
Eligibility Criteria
All adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.
You may qualify if:
- Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
You may not qualify if:
- Chrohn's disease with symptoms of stenosis and/or pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Svendborg, 5700, Denmark
Related Publications (1)
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: 36471059DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 13, 2020
Study Start
May 1, 2020
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
May 20, 2020
Record last verified: 2020-05