Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.
Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking. This study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.
Study Type
OBSERVATIONAL
Enrollment
120
Frankfurt University Hospital
Frankfurt am Main, Hesse, Germany
Establishing a diagnosis from colon capsule endoscopy
Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay, an expected average of 2 weeks after performance of the investigation
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Technical success of colon capsule endoscopy
Technical success is evaluated during the investigation and immediately after to identifal correct technical function of the capsule endoscope including technical performance of the system, battery life of the capsule, passage of colon capsule, review of the capsule video, and documentation
Time frame: At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours
Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events
Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay. Thereby, participants with adverse events attributable to colon capsule endoscopy are assessed and AE characterized.
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Cleansing level of colon capsule endoscopy
Cleansing level of the colon is assessed and qualified as adequate or as not adequate.
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
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