Colon Cancer, Colon Polyp, Diarrhea, Inflammatory Bowel System, Ulcerative Colitis
Conditions
Keywords
Colon capsule endoscopy, Colonoscopy, Screening colonoscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEColon capsule endoscopy
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for colon capsule endoscopy * Age of 18 years or older * Consent of the patient
Exclusion criteria
* Intestinal obstruction * Dyphagia * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establishing a diagnosis from colon capsule endoscopy | At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of colon capsule endoscopy | At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours | 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 |
| Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events | At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation | 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. |
| Cleansing level of colon capsule endoscopy | At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation | Cleansing level of the colon is assessed and qualified as adequate or as not adequate. |
Countries
Germany
Outcome results
None listed