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Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial
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DOI：10.1177/2050640616639162.png)
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Abstract
En 中文
Background Colonoscopes with gradual stiffness have recently been developed to enhance cecal intubation. Objective We aimed to determine if the performance of gradual stiffness colonoscopes is noninferior to that of magnetic endoscopic imaging (MEI)-guided variable stiffness colonoscopes. Methods Consecutive patients were randomized to screening colonoscopy with Fujifilm gradual stiffness or Olympus MEI-guided variable stiffness colonoscopes. The primary endpoint was cecal intubation rate (noninferiority limit 5%). Secondary endpoints included cecal intubation time. We estimated absolute risk differences with 95% confidence intervals (CIs). Results We enrolled 475 patients: 222 randomized to the gradual stiffness instrument, and 253 to the MEI-guided variable stiffness instrument. Cecal intubation rate was 91.7% in the gradual stiffness group versus 95.6% in the variable stiffness group. The adjusted absolute risk for cecal intubation failure was 4.3% higher in the gradual stiffness group than in the variable stiffness group (upper CI border 8.1%). Median cecal intubation time was 13 minutes in the gradual stiffness group and 10 minutes in the variable stiffness group (p < 0.001). Conclusions The study is inconclusive with regard to noninferiority because the 95% CI for the difference in cecal intubation rate between the groups crosses the noninferiority margin. (ClinicalTrials.gov identifier: NCT01895504).
Keywords:
Endoscopy
colonoscopy
innovation
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