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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- Standard colonoscopy | Active Comparator | Standard colonoscopy is performed |
|
| Arm 2- Colonoscopy assisted by Genius | Active Comparator | Colonoscopy assisted by Genius artificial intelligence system is performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genius® System-assisted Colonoscopy | Other | Genius® Intelligence System is used to assist Colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate (ADR) | percentage of colonoscopy with one or more adenoma of the colon | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Advanced Neoplasia Detection Rate (ANDR) | percentage of colonoscopy with one or more advanced neoplasia of the colon | 1 day |
| Proximal Serrated Polyp Detection Rate (PSPDR) | percentage of colonoscopy with one or more serrated polyp of the colon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Karsenti, MD | Clinique Paris-Bercy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Paris-Bercy | Charenton-le-Pont | 94220 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37269872 | Derived | Karsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):726-734. doi: 10.1016/S2468-1253(23)00104-8. Epub 2023 Jun 1. |
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Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
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| Standard Colonoscopy | Other | Standard Colonoscopy without Genius® Intelligence System is performed |
|
| 1 day |
| Polyp Detection Rate (PDR) | percentage of colonoscopy with one or more polyp of the colon | 1 day |
| The factors influencing the Adenoma Detection Rate (ADR) | Withdrawal time (in seconds): time of exploration from the caecum to the anal verge | 1 day |
| The factors influencing the Adenoma Detection Rate (ADR) | Boston scale (0 to 9) | 1 day |
| Time to reach caecum (sec) | Time to reach caecum from the beginning of the procedure (in seconds) | 1 day |
| Caecal intubation rate (%) | Caecal intubation rate (complete colonoscopy) | 1 day |
| Morbidity: perforation rate (%) | Perforation rates (%) | 7 days after procedure |
| Morbidity: bleeding rate (%) | Bleeding rates (%) | 7 days after procedure |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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