Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Division of Gastroenterology, New York University, 550 1st Avenue, New York, 10016, USA.
Dig Dis Sci. 2022 Aug;67(8):4070-4077. doi: 10.1007/s10620-021-07289-4. Epub 2021 Oct 27.
Current strategies to prevent colorectal cancer (CRC) vary considerably regarding safety, invasiveness, and patient satisfaction. A known deterrent for patients is the required bowel cleansing for colonoscopy. A new colon-scan capsule system is a unique preparation-free approach that provides structural information on colonic mucosa intended for detection of colorectal polyps and masses.
The aim of this study was to determine safety and patient satisfaction with the colon-scan capsule.
Prospective single-arm pilot study conducted at two tertiary care centers. Patients with a pre-scheduled colonoscopy for CRC screening or surveillance were included. Patients participating in this study underwent the colon-scan capsule and colonoscopy. Safety was defined by the occurrence of procedure or device-related adverse events. Satisfaction was based on survey questionnaires using a scoring system 1 (strongly disagree) to 5 (strongly agree). Patient satisfaction with the colon-scan capsule was compared to colonoscopy.
Forty patients were included (52.9 [5.7] years; 64.1% females). There were no serious adverse events and no occurrences of capsule retention. The most common (12.5%) complaint was self-limiting abdominal cramping. Satisfaction questionnaires were completed by more than 87% of patients, with patients likely to recommend the capsule (score 4.1 [1.03]) compared to colonoscopy (score 2.8 [1.2]), p = 0.001.
The new prepless colon-scan capsule system is an innovative, minimally invasive technology with demonstrated safety and high patient satisfaction. A multicenter pivotal study is planned to validate the performance, safety, and accuracy of polyp detection using the capsule system in comparison with colonoscopy.
目前预防结直肠癌（CRC）的策略在安全性、侵袭性和患者满意度方面差异很大。患者不愿意接受的一个主要原因是结肠镜检查需要进行肠道清洁。新型结肠扫描胶囊系统是一种独特的无准备方法，它提供了有关结肠黏膜的结构信息，旨在检测结直肠息肉和肿块。
本研究旨在确定结肠扫描胶囊的安全性和患者满意度。
在两家三级护理中心进行前瞻性单臂试点研究。纳入计划进行 CRC 筛查或监测结肠镜检查的患者。参与本研究的患者接受了结肠扫描胶囊和结肠镜检查。安全性通过与操作或设备相关的不良事件来定义。满意度基于问卷调查，使用 1（强烈不同意）到 5（强烈同意）的评分系统。将患者对结肠扫描胶囊的满意度与结肠镜检查进行比较。
共纳入 40 例患者（52.9 [5.7] 岁；64.1%为女性）。无严重不良事件，无胶囊滞留。最常见的（12.5%）抱怨是自限性腹痛。超过 87%的患者完成了满意度调查问卷，与结肠镜检查相比，患者更愿意推荐胶囊（评分 4.1 [1.03]），而不是结肠镜检查（评分 2.8 [1.2]），p=0.001。
新型无准备结肠扫描胶囊系统是一种创新的、微创技术，具有良好的安全性和高患者满意度。计划进行一项多中心关键性研究，以验证该胶囊系统在检测息肉方面的性能、安全性和准确性，并与结肠镜检查进行比较。
