Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial

BACKGROUND: Colonoscopes are designed with balance between flexibility, required to negotiate angulations, and stiffness, required to counteract the propensity for looping in unfixed sections of the colon, which retards advancement of the instrument. Colonoscopy can be challenging with old instruments that have lost native stiffness and become less responsive to torquing. A new intraluminal stiffening device has become available in two grades of stiffness. However, there is no published evidence of its effectiveness. This randomized, controlled trial was designed to determine the effectiveness of the stiffening wires in improving cecal intubation rate and time following routine application. A secondary analysis determines effectiveness of application only after intractable failure with the unaided colonoscope. METHODS: The colonoscope tested was an Olympus CF-100TL, approximately fifteen years old. Patients were randomly assigned to the unaided colonoscope or the standard or firm wire introduced routinely on entry into transverse colon. Each phase of colonoscopy was timed. Failure to advance the colonoscope for 5 minutes (despite usual manipulations to minimize looping) required switching to another intervention according to a prescribed methodology and the originally assigned intervention was recorded as failed. RESULTS: The study was terminated after accrual of 112 participants (target sample size 480) because the colonoscope required repairs (no damage attributable to stiffening wires) which would have been uneconomical. There were no statistically significant differences between per-protocol cecal intubation rates (81.1, 71.1 and 70.3 percent respectively), a finding which persisted after multiple imputation for a virtual sample size of 480. Similarly, there were no statistically significant differences between per-protocol cecal intubation times (15, 16.2 and 13.9 minutes). However, a statistically significant improvement in cecal intubation rate (from 81.1% to 97.3%, P = 0.0313) was achieved when the wires were applied after intractable failure of the unaided colonoscope in the first intervention group. CONCLUSIONS: Routine application of either stiffening wire does not improve caecal intubation rate nor time compared to the unaided colonoscope. However, application of the stiffening wires after intractable failure of the unaided colonoscope enabled a statistically significant improvement in cecal intubation rate. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01115010