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Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial
Kjetil Garborg1, Håvard Wiig2, Audun Hasund2
1Department of Medicine, Sorlandet Hospital, Kristiansand, Norway; Department of Transplantation Medicine, Section of Gastroenterology, Oslo University Hospital, Norway; Department of Health Economy and Health Management and KG Jebsen Center of Colorectal Cancer Research, University of Oslo, Norway.
United European Gastroenterology Journal
|April 14, 2017
Summary
New gradual stiffness colonoscopes did not prove noninferior to magnetic endoscopic imaging (MEI)-guided variable stiffness scopes for cecal intubation. Cecal intubation rates were similar, but the study could not confirm noninferiority.
Area of Science:
- Gastroenterology
- Medical Devices
- Clinical Trials
Background:
- Colonoscopes with gradual stiffness have been developed to improve cecal intubation success.
- This study compares their performance against magnetic endoscopic imaging (MEI)-guided variable stiffness colonoscopes.
Purpose of the Study:
- To determine if gradual stiffness colonoscopes are noninferior to MEI-guided variable stiffness colonoscopes in terms of cecal intubation rate.
- To compare cecal intubation time between the two types of colonoscopes.
Main Methods:
- A randomized controlled trial involving 475 patients undergoing screening colonoscopy.
- Patients were assigned to either Fujifilm gradual stiffness or Olympus MEI-guided variable stiffness colonoscopes.
- The primary endpoint was the cecal intubation rate, with a noninferiority margin of 5%.
Main Results:
- Cecal intubation was achieved in 91.7% of patients with gradual stiffness scopes versus 95.6% with variable stiffness scopes.
- The gradual stiffness group had a 4.3% higher adjusted absolute risk of cecal intubation failure.
- Cecal intubation time was longer in the gradual stiffness group (13 minutes) compared to the variable stiffness group (10 minutes).
Conclusions:
- The study is inconclusive regarding the noninferiority of gradual stiffness colonoscopes.
- The 95% confidence interval for the cecal intubation rate difference crossed the predefined noninferiority margin.
- Further research may be needed to fully evaluate the efficacy of gradual stiffness colonoscopes.