A new fiberoptic sigmoidoscopic system has been developed that utilize
s a disposable sheath to cover and protect all working surfaces of the
endoscope from contamination. The reusable part of the endoscope has
no air, water, or suction/biopsy channels. These are incorporated in t
he disposable sheath, which is easily removed after use to provide eac
h patient with a contamination-free endoscope. A prospective, randomiz
ed, controlled trial was performed to compare the disposable, sheathed
, flexible sigmoidoscope with standard sigmoidoscopes. Clinical evalua
tions of the new sigmoidoscope system were performed at 15 facilities.
Visual analog rating scales were used to record evaluations of endosc
ope performance and reprocessing by endoscopists and reprocessing pers
onnel. The time to perform procedures, depth of insertion, and total i
nstrument downtime were also recorded. One hundred forty-three procedu
res (70 standard, 73 sheathed) were performed. No significant differen
ce was found for overall depth of insertion (50 versus 48 cm), althoug
h fewer sheathed endoscopes reached to 60 cm than did standard endosco
pes (51% versus 30%). The sheathed system had a slightly longer mean p
rocedure time than the standard (5.6 versus 6.7 minutes), but a signif
icantly shortened overall downtime (32.8 vs 8.1 minutes). The standard
system was preferred by the endoscopists. Reprocessing personnel pref
erred the disposable system. The disposable sigmoidoscope system has i
mportant advantages of decreased instrument turn-around time and poten
tially increased staff and patient safety, and future models should be
improved to meet physicians' concerns.