Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
SOCRATEC
SOCRATEC
Sponsor study identifier
observational
600
1 country
1
Study Start
May 1, 2020
Actual (reported)Primary Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2020
Actual (reported)March 13, 2020
Actual (reported)May 1, 2020
Actual (reported)October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.
Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.
Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.
Endoscopy performed using PillCam2 camera capsule for oral ingestion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Odense University Hospital
Svendborg, 5700, Denmark
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.
First Submitted
March 12, 2020
First Posted
March 13, 2020
Study Start
May 1, 2020
Actual (reported)Primary Completion
October 1, 2030
EstimatedAccuracy for Predicting Deep Submucosal Invasion
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 20, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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