A motor-driven single-use colonoscope controlled with a hand-held device: a feasibility study in volunteers.

TY - JOUR

T1 - A motor-driven single-use colonoscope controlled with a hand-held device: a feasibility study in volunteers.

AU - Rösch, Thomas

AU - Adler, Andreas

AU - Pohl, Heiko

AU - Wettschureck, Elke

AU - Koch, Martin

AU - Wiedenmann, Bertram

AU - Hoepffner, Nicolas

PY - 2008

Y1 - 2008

N2 - BACKGROUND: Several new instruments have been developed in the effort to improve the acceptance of colonoscopy for colorectal cancer screening. A new colonoscope, the Invendoscope, is presented here. It consists of an endoscopic sheath with an inverted sleeve, instrument channel, and an electrohydraulic deflecting tip. The instrument is steered by a hand-held device and propelled by a motorized drive unit. OBJECTIVE: Our purpose was to evaluate the feasibility of the new Invendoscope SC40. DESIGN: Prospective single-arm pilot study over 2 time periods using 2 different instrument prototypes (170 and 180/200 cm). PATIENTS: Thirty-four healthy volunteers (19 men, mean age 49.7 years). Technical instrument defects led to premature termination in 5 additional volunteers during the 2 study periods (4 in phase 1, 1 in phase 2), who were excluded from further analysis. INTERVENTIONS: Total colonoscopy was attempted, with all procedures being performed without sedation. MAIN OUTCOME MEASUREMENTS: Cecal intubation rate. RESULTS: The cecum was reached in 82% of the 34 cases (95% CI, 66%-92%), with better results in period 2 than in period 1 (90% vs 79%); of the 6 incomplete examinations, 4 reached the mid transverse colon or beyond and 2 were stopped in the sigmoid colon because of pain. The volunteer rating showed a mean score of 1.96 (range 1-6; 1 = no discomfort). No complications were encountered. LIMITATIONS: No data regarding diagnostic accuracy and no data comparing the instrument with conventional colonoscopy are available as yet. CONCLUSIONS: This pilot proof-of-principle study of a new motor-driven colonoscope showed promising cecal intubation rates and an absence of pain in 92% of cases. Further clinical and comparative studies are warranted.

AB - BACKGROUND: Several new instruments have been developed in the effort to improve the acceptance of colonoscopy for colorectal cancer screening. A new colonoscope, the Invendoscope, is presented here. It consists of an endoscopic sheath with an inverted sleeve, instrument channel, and an electrohydraulic deflecting tip. The instrument is steered by a hand-held device and propelled by a motorized drive unit. OBJECTIVE: Our purpose was to evaluate the feasibility of the new Invendoscope SC40. DESIGN: Prospective single-arm pilot study over 2 time periods using 2 different instrument prototypes (170 and 180/200 cm). PATIENTS: Thirty-four healthy volunteers (19 men, mean age 49.7 years). Technical instrument defects led to premature termination in 5 additional volunteers during the 2 study periods (4 in phase 1, 1 in phase 2), who were excluded from further analysis. INTERVENTIONS: Total colonoscopy was attempted, with all procedures being performed without sedation. MAIN OUTCOME MEASUREMENTS: Cecal intubation rate. RESULTS: The cecum was reached in 82% of the 34 cases (95% CI, 66%-92%), with better results in period 2 than in period 1 (90% vs 79%); of the 6 incomplete examinations, 4 reached the mid transverse colon or beyond and 2 were stopped in the sigmoid colon because of pain. The volunteer rating showed a mean score of 1.96 (range 1-6; 1 = no discomfort). No complications were encountered. LIMITATIONS: No data regarding diagnostic accuracy and no data comparing the instrument with conventional colonoscopy are available as yet. CONCLUSIONS: This pilot proof-of-principle study of a new motor-driven colonoscope showed promising cecal intubation rates and an absence of pain in 92% of cases. Further clinical and comparative studies are warranted.

M3 - SCORING: Zeitschriftenaufsatz

VL - 67

SP - 1139

EP - 1146

JO - GASTROINTEST ENDOSC

JF - GASTROINTEST ENDOSC

SN - 0016-5107

IS - 7

M1 - 7

ER -