Colon Adenoma Clinical Trial
— SNOWCATVerified date | October 2016 |
Source | Technische Universität München |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. A minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. However, different locations of the colon (proximal, distal) may require specific observation time periods. The colon can be divided into a proximal (right) and distal (left) part. Until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. The aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.
Status | Completed |
Enrollment | 500 |
Est. completion date | April 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
Inclusion Criteria: - indication for colonoscopy - age = 40 years Exclusion Criteria: - American Society of Anesthesiologists class IV or higher - pregnant women - indication for colonoscopy: inflammatory bowel disease - indication for colonoscopy: polyposis syndrome - indication for colonoscopy: emergency colonoscopy e.g. acute bleeding - contraindication for polyp resection e.g. patients on warfarin |
Country | Name | City | State |
---|---|---|---|
Germany | II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München | Munich |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma detection rate in the proximal colon | After obtaining the histopathological diagnosis of resected polyps (approximately 3 -6 days) it can be determined whether the resected polyp contained adenomatous histology or not. | up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) | |
Secondary | Polyp detection rate | a maximum of one day is expected for colonoscopy procedures | up to one day |
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