This article describes a 15-center, randomized control trial by Rothstein et al in which the function and reprocessing of a first-generation sheathed flexible sigmoidoscope (Vision System, Vision Sciences, Natick, MA) were compared with those of standard endoscopes (Fujinon, Wayne, NJ; Olympus, Lake Success, NY; or Pentax, Orangeburg, NY). The study include 143 flexible sigmoidoscopy procedures, 73 of which were done with the sheathed endoscope and 70 with a standard device. Twenty-four endoscopists and 30 reprocessing staff members (nurses and assistants) participated in the study.
The following data were recorded for each procedure: endoscope setup time, reprocessing time (cleaning and disinfecting), total instrument downtime (setup time plus reprocessing time), depth of endoscope insertion, and duration of procedure. The endoscopists and reprocessing personnel evaluated numerous handling, design, and reprocessing characteristics of the sheathed and standard endoscopes by using a 100-point visual analog scale (VAS), with 100 indicating a perfect score (an imagined “ideal” endoscope) and 0 the worst possible score. The standard endoscopes were reprocessed in accordance with the usual protocol at each center. Reprocessing of the sheathed endoscope system was done in accordance with the manufacturer’s recommendations.
The study found that procedures using the sheathed sigmoidoscope system took a mean of about 1 minute longer than those done with a standard endoscope. The mean reprocessing time and total downtime were significantly shorter with the sheathed endoscope (31 versus 3 minutes and 33 versus 8 minutes, respectively; P < 0.00005 for both comparisons). The endoscopists preferred the standard sigmoidoscopes over the sheathed device with respect to each handling characteristic assessed, as well as overall (mean, 82 versus 68 points on the VAS), although not all differences were statistically significant. In contrast, reprocessing personnel favored the sheathed system for every characteristic and overall (79 versus 62 points; P < 0.00005).
Rothstein et al commented that the downtime for reprocessing of standard sigmoidoscopes is a major factor in delay between procedures and that a sizable supply of endoscopes is required in order to have an instrument ready for the next patient; therefore, the markedly decreased turnaround time is an important advantage of the sheathed sigmoidoscope system. Moreover, according to the authors, the high-level disinfection required for standard endoscopes places patients and staff at risk of reactions to disinfection solutions. In addition, reprocessing errors that resulted in contaminated “patient-ready” endoscopes have been reported. Rothstein et al concluded that use of an EndoSheath® barrier may reduce the risk of endoscopically transmitted infections and increase patient and staff safety. They also noted that future refinements in the sheathed system will likely improve the features about which the endoscopists in their study expressed concern.
