Nationwide multicenter prospective study on the usefulness, safety, and acceptability of colon capsule endoscopy in Japan.

Background and aims: We determined the factors influencing total capsule colonoscopy, adequate cleansing, and detectability of second-generation colon capsule endoscopy (CCE) for colorectal polyps or tumors (CRTs), adverse events, and acceptability.

Methods: Among 44 Japanese hospitals, 1006 patients with suspected or documented colorectal diseases who underwent CCE were enrolled prospectively.

Results: The total capsule colonoscopy rate was 86.1%. Age younger than 63 years (adjusted odds ratio [aOR], 1.525), male sex (aOR, 1.496), inflammatory bowel disease (aOR, 1.889), lavage intake on day -1 (aOR, 1.625), ≥1800-mL lavage intake on day 0 (aOR, .595), prokinetics on day 0 (aOR, .608), and ≥30-mL castor oil booster on day 0 (aOR, 1.734) were significant independent predictors. The overall adequate cleansing rate was 65.5%. Constipation (aOR, .527), lavage intake on day -1 (aOR, 1.822), laxative intake on day -1 (aOR, 2.616), and ≥1900-mL lavage intake on day 0 (aOR, 1.449) were significant independent predictors. The detection rates for patients with CRTs ≥6 mm and ≥10 mm were 92% (95% confidence interval, 84-97) and 89% (95% confidence interval, 78-96), respectively. Inadequate cleansing in the ascending colon (aOR, .184), ≥6-mm CRT in the transverse colon (aOR, 4.703), and ≥6-mm CRT in the left-sided colon (aOR, 32.013) were significant independent predictors. CCE retention occurred in 2 patients (.20%) requiring endoscopic and surgical interventions. In total, 63% of patients desired CCE for their next colonoscopy.

Conclusions: CCE was relatively safe, well tolerated, and useful for detecting colorectal lesions when adequate bowel preparation was made. (Clinical trial registration number: UMIN000021936.).