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Full Spectrum Endoscopy (FUSE) colonoscopy versus conventional forward-viewing colonoscopy in the detection of dysplasia in patients with chronic inflammatory bowel diseases .

ABSTRACT: Interventions: Randomized order of colonoscopy type (conventional versus FUSE colonoscopy) to determine the miss rates of colonoscopy type. The intervention is the use of the FUSE colonoscope which is a colonoscope that incorporates 3 cameras on the colonoscope tip to provide a panoramic 330-degree field of view. .The size and function of the FUSE colonoscope is otherwise the same as the conventional colonoscope (control). Both instruments visualise the internal lining of the bowel and permit the identification and removal of neoplasia. All subjects will have both procedures performed back-to-back (crossover tandem colonoscopy) but the order of the procedure will be randomized. The effect is that the second procedure will determine if lesions were missed during the first procedure, and which colonoscope can identify more neoplasia. Both colonoscopies are expected to be equivalent in duration, taking 15-25 minutes. Quality indicator is that colonoscopy withdrawal should be of at least 6 minutes to improve the chances of not missing pathology. Both colonoscopies are conducted by investigators who are experienced in surveillance colonoscopies and accredited endoscopists. The histopathologists are from the Department of Pathology and familiar with the identification and interpretation of IBD dysplasia. Where dysplasia is found, a second gastrointestinal pathologist will assist with the grading through consensus. Both pathologists are blinded to the order of the colonoscopy (which is coded). There is no need for a wash out, as this is not a drug trial. The second colonoscopy is inserted as soon as the processor is connected and switched on, which usually takes 4-5 minutes. The patient remains under sedation during the intervening period and we wish to keep that as brief a Primary outcome(s): Dysplasia miss rates on a per-lesion analysis [Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety/efficacy

DISEASE(S): Inflammatory Bowel Diseases,Oral And Gastrointestinal-inflammatory Bowel Disease,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2463098 | 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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Full Spectrum Endoscopy (FUSE) colonoscopy versus conventional forward-viewing colonoscopy in the detection of dysplasia in patients with chronic inflammatory bowel diseases .

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