The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.
Study Type
OBSERVATIONAL
Enrollment
15,816
Detachable disposable (single-use) device that fits over the distal colonoscope end.
Forzani and MacPhail Colon Cancer Screening Centre (CCSC)
Calgary, Alberta, Canada
Adenoma detection rate (ADR)
Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed
Time frame: Intra-procedural
Adenoma detection rate among patients with positive fecal immunochemical tests
Proportion of an endoscopist's colonoscopies performed for +fecal immunochemical test (FIT), or indications other than positive FIT during which one or more adenoma was biopsied or removed. In order to be included in the non-FIT ADR category, a patient must not have undergone a colonoscopy at CCSC within the last four years of the index procedure.
Time frame: Intra-procedural
SSADR (sessile serrated adenoma detection rate)
Proportion of an endoscopist's screening-related colonoscopies during which one or more sessile serrated adenoma was biopsied or removed
Time frame: Intra-procedural
CIR (cecal intubation rate)
Proportion of an endoscopist's screening-related procedures in which the cecal pole is intubated, as landmarked by direct visualization of the appendiceal orifice, ileocecal valve, or both.
Time frame: Intra-procedural
Procedure time
Total time spent by an endoscopist from the start of the colonoscopy procedure (insertion of the colonoscope through the anus) to the end of the colonoscopy (removal of the colonoscope from the anus). This variable will be calculated only for cases in which no pathology was encountered.
Time frame: Intra-procedural
Nurse-assessed patient comfort scores (NAPCOMs)
Validated score for determining patients' procedural comfort. Scored from 0 to 9, with higher scores indicating higher discomfort intensity, frequency, and/or duration.
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Time frame: Intra-procedural
Number of patients with immediate adverse events
Adverse events occurring at the time of colonoscopy or before discharge, including bleeding or perforation.
Time frame: Day 1
Number of patients with delayed adverse events
Adverse events within 30 days of the index procedure, including delayed bleeding, delayed perforation, or acute healthcare utilization (emergency department visit or hospital admission) for any other reasons deemed related to index colonoscopy.
Time frame: Within 30 days of index procedure