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 1st and 2nd 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.
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机译：目的评估新的结肠胶囊内窥镜（CCE）肠道准备方案的清洁效果和安全性。方法这是一项多中心，前瞻性，随机对照研究，比较了两种CCE方案。受试者无症状，平均患大肠癌的风险。使用了第二代CCE系统（PillCam ？ COLON 2;以色列约克尼姆的美敦力公司）。在研究方案中，口服硫酸盐溶液（89 mL）与泛影酸葡甲胺和泛影酸钠溶液（“泛影酸溶液”）的研究方案在第1次和第二次加强免疫时有所不同（升压1 = 60 mL，升压2 = 30 mL）和对照方案口服硫酸盐溶液（89 mL）。主要结局是整体和节段性结肠清洗。次要结果包括安全性，息肉检测，结肠转运，CCE完成和胶囊排泄≤12 h。结果两种方案对整个结肠和单独的部分具有相似的清洁效果（足够：研究= 75.9％，对照= 77.3％; P = 0.88）。在研究组中，CCE完成率较高（研究= 90.9％，对照= 76.9％; P = 0.048），结肠转运更常见地是<40分钟（研究= 21.8％，对照= 4％; P = 0.0073）。更多的研究方案受试者经历了不良事件（研究= 19.4％，对照组= 3.4％; P = 0.0061），并且这种差异似乎与泛影溶液无关。不良事件本质上主要是胃肠道疾病，没有观察到与肠道准备方案或胶囊有关的严重不良事件。研究方案有更高的息肉检出趋势，但对于任何大小类别均未达到统计学意义。研究方案从摄食到排泄的整个胃肠道的平均通过时间较短，而两个研究组的平均结肠通过时间相似。结论采用口服硫酸盐溶液和泛影酸盐溶液作为促进剂的CCE肠准备方案是有效，安全的，并实现了优异的CCE完全性。
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