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Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04307901
Acronym
SOCRATEC
Enrollment
600
Registered
2020-03-13
Start date
2020-05-01
Completion date
2030-12-31
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Polyp

Keywords

colon capsule endoscopy, ct colonography, colonoscopy, endoscopy

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.

Interventions

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complete mucosal visualization combining incomplete investigations10 yearsBy combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.

Secondary

MeasureTime frameDescription
Completion rate of colon capsule endoscopy2 yearsTotal and subgroup completion rates of investigations
Safety of colon capsule endoscopy1 yearTotal and subgroup safety of investigations
Quality of colon capsule endoscopy1 yearSensitivity and specificity compared to colonoscopies
Economic evaluation1 yearEconomic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.
Patient preference2 yearsInvestigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures

Countries

Denmark

Contacts

Primary ContactGunnar Baatrup, Prof.
gunnar.baatrup@rsyd.dk+4520575154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026