Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Gastroenterology and Hepatology, University of Mainz, Mainz, Germany.
Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.
The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons.
This multicenter feasibility study included patients aged 18 - 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety.
47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 - 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; < 0.001) and median BBPS score (from 3.0 [IQR 0.0 - 5.0] to 9.0 [IQR 8.0 - 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0-28.3) and 34.0 minutes (IQR 25.0 - 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period.
This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.
高质量的术前肠道准备至关重要，但在多达 20%的结肠镜检查患者中，肠道清洁效果仍不理想。本研究旨在评估一种新型术中肠道清洁设备对肠道准备不良患者的清洁效果。
本多中心可行性研究纳入了年龄在 18-75 岁之间，因结肠镜检查而就诊的患者。在接受有限的术前肠道准备方案（2 天饮食限制和 2×10mg 比沙可啶）后，对患者进行术中清洁。主要结局是使用新型设备进行节段性清洗前后肠道准备充分（Boston 肠道准备评分[BBPS]每段均≥2）的患者比例。次要结局包括：盲肠插管率、操作时间、系统可用性、患者满意度和安全性。
在三个临床中心共纳入了 47 名患者（42.6%为男性），中位年龄为 61 岁（四分位间距[IQR]46-67 岁）。47 名患者中有 46 名（97.9%）成功插管。该清洁设备显著提高了肠道清洁充分的患者比例（从 19.1%提高到 97.9%；<0.001）和中位 BBPS 评分（从 3.0[IQR 0.0-5.0]提高到 9.0[IQR 8.0-9.0]）。盲肠插管时间和总操作时间的中位数分别为 16.5 分钟（IQR 9.0-28.3）和 34.0 分钟（IQR 25.0-42.8）。医生对设备的易用性感到满意，患者也能很好地耐受。研究期间未发生严重不良事件。
这项可行性研究表明，该术中肠道清洁设备在将肠道准备不良的肠道清洁至充分水平方面安全有效，可进行全面的结直肠检查。
