Format

Send to

Choose Destination
United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.

Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial.

Author information

1
Department 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.
2
Department of Medicine, Sorlandet Hospital, Kristiansand, Norway.
3
Department of Medicine, Sorlandet Hospital, Kristiansand, Norway; Department of Health Economy and Health Management and KG Jebsen Center of Colorectal Cancer Research, University of Oslo, Norway.
4
Department of Medicine, Sorlandet Hospital, Arendal, Norway.
5
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.
6
Department of Health Economy and Health Management and KG Jebsen Center of Colorectal Cancer Research, University of Oslo, Norway; Telemark Hospital, Skien, Norway.
7
Department of Health Economy and Health Management and KG Jebsen Center of Colorectal Cancer Research, University of Oslo, Norway; Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

Abstract

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

Supplemental Content

Full text links

Icon for PubMed Central Icon for Norwegian BIBSYS system
Loading ...
Support Center