Disposable, sheathed, flexible sigmoidoscopy: A prospective, multicenter, randomized trial,☆☆,,★★,,♢♢,

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Abstract

A new fiberoptic sigmoidoscopic system has been developed that utilizes 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 the disposable sheath, which is easily removed after use to provide each patient with a contamination-free endoscope. A prospective, randomized, controlled trial was performed to compare the disposable, sheathed, flexible sigmoidoscope with standard sigmoidoscopes. Clinical evaluations of the new sigmoidoscope system were performed at 15 facilities. Visual analog rating scales were used to record evaluations of endoscope performance and reprocessing by endoscopists and reprocessing personnel. The time to perform procedures, depth of insertion, and total instrument downtime were also recorded. One hundred forty-three procedures (70 standard, 73 sheathed) were performed. No significant difference was found for overall depth of insertion (50 versus 48 cm), although fewer sheathed endoscopes reached to 60 cm than did standard endoscopes (51% versus 30%). The sheathed system had a slightly longer mean procedure time than the standard (5.6 versus 6.7 minutes), but a significantly shortened overall downtime (32.8 vs 8.1 minutes). The standard system was preferred by the endoscopists. Reprocessing personnel preferred the disposable system. The disposable sigmoidoscope system has important advantages of decreased instrument turn-around time and potentially increased staff and patient safety, and future models should be improved to meet physicians' concerns. (Gastrointest Endosc 1995;41:566-72.)

Section snippets

METHODS

The protocol for this study was devised and executed by the authors at the request of the manufacturer. The manufacturer did not take part in the design of the study or the analysis of the data. The authors have no financial interest in Vision Sciences, Inc., and costs of the study were borne by the manufacturer. The Institutional Review Board at each site approved the protocol.

The 15 facilities chosen by the authors represent diverse geographic areas and practice settings at university

RESULTS

One hundred forty-three flexible sigmoidoscopies were performed at 15 study sites. A total of 24 endoscopists and 30 reprocessing personnel (nurses and assistants) participated in the study and rated up to 10 procedures each. Seventy-three sigmoidoscopies were done with the disposable sheathed system, and 70 were done with standard endoscopes. The results are presented in Table 1. The differences in age, sex, height, and indication for endoscopy were not significant between study groups. The

DISCUSSION

In a comprehensive review of the literature, contributing causes of endoscope-transmitted infection were improper cleaning and disinfection, contamination of automated reprocessing machines, and the complex arrangement of channels and valves in the instrument.19 Studies of the interior surfaces of endoscope channels have documented debris, damage, and structural design that may prevent adequate cleaning and disinfection.20, 21

In addition to the potential for infective complications, current

Acknowledgements

The Disposable Endoscope Study Group includes the following individuals and institutions (Principal Investigators are listed first):

University of Colorado, Denver VAMC, Denver, Colorado: Dennis Ahnen, MD; Susie Fredrick, RN.

Tufts Medical School, Baystate Medical Center, Springfield, Massachusetts: Canan Avunduk, MD, PhD; Mark A. Hirschkorn, MD; Mary Ann Huse, RN; Virginia Shute, LPN.

Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts: David Carr-Locke, MD; David

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    From the Section of Gastroenterology and the Technology Assessment Program, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.

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    Dr. Littenberg is an American College of Physicians George Morris Piersol Teaching and Research Scholar.

    This work was supported by Vision Sciences, Inc.

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    Reprint requests: Richard I. Rothstein, MD, Section of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756.

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    GASTROINTESTINAL ENDOSCOPY

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