Endosheath - a disposable, sheathed, flexible gastroscopy - a prospective randomized trial

The reprocessing of flexible gastrointestinal endoscopes is time-consuming and expensive. Endoscopically transmitted infections due to insufficient disinfection are already of clinical importance. A new developed prototype of a flexible, fiberoptic gastroscope was tested in a prospective open randomized trial to evaluate the function. reprocessing and hygienical safety of this disposable, sheathed endoscopic system and was compared with a standard gastroscope. This new endoscopical system utilizes a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. A prospective, randomized trial was performed in our unit to compare the disposable gastroscope (G-F100) with a standard-gastroscope of the newest Generation (GIF-Q 30). Visual analog rating scales were used to record evaluations of endoscope performance and reprocessing by endoscopists and reprocessing personnel. We recorded the time of reprocessing, the time to perform the procedures, depth of insertion, total instrument downtime and any problems which occurred during the procedure. Microbiological swabs were taken from each endoscope. 40 procedures (20 standard, 20 sheathed) were performed. The sheathed gastroscope 8,9 min versus 7,1 min. The overall instrument downtime was significantly shortened by the endosheath (9,8 min versus 47,5 min with the standard gastroscope). The disposable gastroscope-system permits an increase of procedure-frequency up to a factor of 2,9. The standard gastroscope was preferred by the endoscopists and the reprocessing personnel. No microbiological contaminations of the sheathed or the standard gastroscopes could be demonstrated, and no leak of the sheaths was recorded after gastroscopy. The disposable gastroscope has important advantages of decreased instrument turn-around time and potentially increased staff and patient safety.