Multicenter, randomized study to optimize bowel preparation for colon capsule endoscopy

Abstract

Aim: To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.

Methods: This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam^® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1^st and 2^nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution ("diatrizoate solution") (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ≤ 12 h.

Results: Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups.

Conclusion: A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.

Keywords: Bowel preparation; Capsule colonoscopy; Capsule endoscopy; Endoscopy; Large intestine; Purgative.

Figure 1

Patient flow diagram. ¹Group A received any of the CCE preparation regimen = Baseline subject characteristics, safety analysis, comparisons between Control regimen and Rex et al[1] and between Study regimen and Spada et al[15] for colon capsule completion and transit times. ²Group B excluded subjects who withdrew before capsule ingestion, had a protocol violation, or experienced technical failure of the capsule = Colon cleansing by segment, CCE completion, CCE transit times, polyp detection by colon segment, comparisons between Control regimen and Rex et al[1] for colon cleansing by segment. ³Group C excluded subjects listed above (B), and those with non-visualization of the cecum, right colon, or transverse colon = Colon cleansing for whole colon, polyp detection for the whole colon, comparisons between the Control regimen and Rex et al[1] and between the Study regimen and Spada et al[15] for overall cleansing of the colon. ⁴Group D excluded subjects listed above (B and C) and those with both inadequate overall colon cleansing and colonic transit time < 40 min = Comparisons between Control regimen and Rex et al[1] and Study regimen and Spada et al[15] for whole colon polyp detection.