Clinique Paris-Bercy
Charenton-le-Pont, 94220, France
NCT Number: NCT04112563
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Charenton-le-Pont, 94220, France
All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.
A- Inclusion criteria:
Exclusion criteria
History of recto-colic resection Inadequate preparation (none under Boston score <2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis
B- Exclusion criteria:
Purposes of the study:
Compare, when exploring the number of adenomas missed by the first exploration of the right colon by LCI or by white light, according to the order of randomization.
Evaluation criteria :
Main criterion:
Secondary criteria
Number of patients:
The expected rate of "missed adenomas" of the colon is about 20%, based on published data. Considering as relevant an 8% reduction in this rate of "missed adenomas" of the right colon by the LCI, the expected rate for LCI is therefore 12%.
With a risk of the first species of 5% (bilateral test), a power of 80%, 329 patients per group should be included in the study. Taking into account the rate lost to follow-up of 5%, we expect a total of 700 patients.
Duration of the study:
1-2 years
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exploration of the right colon done in white light (WLI)
Exploration of the right colon in linked color imaging (LCI)
Time frame: 1 day
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
Time frame: 1 day
Time of exploration (in seconds)
Time frame: 1 day
Boston scale (0 to 9)
Time frame: 1 day
Size in millimeters
Time frame: 1 day
type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp
Time frame: 1 day
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon
Time frame: 1 day
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon
Time frame: 1 day
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon
Société Française d'Endoscopie Digestive
Other
COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
Acronym: COCORICO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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