Odense University Hospital
Svendborg, 5700, Denmark
Location status: Recruiting
Location contact
Gunnar Baatrup
CONTACT
NCT Number: NCT04307901
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Svendborg, 5700, Denmark
Location status: Recruiting
Gunnar Baatrup
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endoscopy performed using PillCam2 camera capsule for oral ingestion
Time frame: 10 years
By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.
Time frame: 2 years
Total and subgroup completion rates of investigations
Time frame: 1 year
Total and subgroup safety of investigations
Time frame: 1 year
Sensitivity and specificity compared to colonoscopies
Time frame: 1 year
Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.
Time frame: 2 years
Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures
Contact information is provided by the study sponsor or research team.
Odense University Hospital
Other
Acronym: SOCRATEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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