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ColoAssist vs. MEI

ABSTRACT: Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.

DISEASE(S): Screening,Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2148016 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: WAC intervention, Colonoscopist use water to inflate the colon instead of air during insertion the colonoscope. The sterile water at room temperature is pumped into the system. Patient demographics, which are age, sex, weight, height, and waist circumference are recorded prior to a colonoscopy procedure. Vital sign is measured in all patients, that are blood pressure, heart rate and oxygen saturation. Prior to a colonoscopy procedure, the patient is positioned on their left side, and a transparent cap is attached to the tip of the colonoscope. In addition, all patients are typically administered 2 mg of midazolam intravenously for sedation during the procedure. Once the colonoscope is inserted, the air pump is turned off. Cecal intubation time is recorded when colonoscopist reach to the cecal floor, appendix orifice and the opening of terminal ilium. These landmark is indicators of a successful intubation of the entire colon. To evaluate the level of pain experienced by the patient during a colonoscopy procedure, a 10-points scale is used. This scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. During the procedure, the nurse will ask the patient to provide their pain score every 3 minutes using the visual analog scale. If patient's pain score is greater than 3 or if the patient requests it, intravenous fentanyl (25 mcg) is administered to provide pain control. Vital sign is measured every 5 minutes during colonoscopy. During the withdrawal phase of colonoscopy procedure, air can be used to inflate the colon as usual. The time elapsed since reaching the cecal floor and the anus is recorded, and the timer is stopped when any procedure interventions, such as polypectomy or tis;Experimental Procedure/Surgery,Active Comparator Procedure/Surgery;Water-assisted colonoscopy,Carbon dioxide insufflation colonoscopy Primary outcome(s): The difficulty technique of colonoscopy between water-assisted colonoscopy and carbon dioxide colonoscopy in beginner 2 months after the end of intervention Cecal intubation time Study Design: Randomized

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ColoAssist vs. MEI

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