Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
Time frame: Colonoscopy time
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
Time frame: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
Time frame: Colonoscopy time
Rate of complications
Global and for each arm
Time frame: Colonoscopy time and 1 month after
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
Time frame: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
Time frame: Colonoscopy time
G-EYE assistance for endoscope stabilization
Yes or no
Time frame: Colonoscopy time
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