Colorectal Adenoma
Conditions
Brief summary
The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.
Interventions
DEVICEFUSE-TM colonoscope
Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.
Sponsors
Institut Paoli-Calmettes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Diagnostic colonoscopy
Exclusion criteria
* Colorectal cancer * Colic surgery * Preparation of average or poor quality * Rectal polyp of hyperplastic type \<2 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 1 day | Cecal intubation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 1 day | Serious adverse events (perforation, uncontrolled bleeding) |
Countries
France
Outcome results
None listed