This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy. The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).
Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited. The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits). A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study. After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy. This randomization will be done in the computer examination room using the randomization software. The patient will therefore be randomized into 2 groups: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system will be made as following: A-Main criterion: \- Adenoma detection rate (ADR) B-Secondary criteria: Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors associated with ADR
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,100
Genius® Intelligence System is used to assist Colonoscopy
Standard Colonoscopy without Genius® Intelligence System is performed
Clinique Paris-Bercy
Charenton-le-Pont, France
Adenoma Detection Rate (ADR)
percentage of colonoscopy with one or more adenoma of the colon
Time frame: 1 day
Advanced Neoplasia Detection Rate (ANDR)
percentage of colonoscopy with one or more advanced neoplasia of the colon
Time frame: 1 day
Proximal Serrated Polyp Detection Rate (PSPDR)
percentage of colonoscopy with one or more serrated polyp of the colon
Time frame: 1 day
Polyp Detection Rate (PDR)
percentage of colonoscopy with one or more polyp of the colon
Time frame: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Withdrawal time (in seconds): time of exploration from the caecum to the anal verge
Time frame: 1 day
The factors influencing the Adenoma Detection Rate (ADR)
Boston scale (0 to 9)
Time frame: 1 day
Time to reach caecum (sec)
Time to reach caecum from the beginning of the procedure (in seconds)
Time frame: 1 day
Caecal intubation rate (%)
Caecal intubation rate (complete colonoscopy)
Time frame: 1 day
Morbidity: perforation rate (%)
Perforation rates (%)
Time frame: 7 days after procedure
Morbidity: bleeding rate (%)
Bleeding rates (%)
Time frame: 7 days after procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.