Bevan Roisin, Ngu Wee Sing, Saunders Brian P, Tsiamoulos Zacharias, Bassett Paul, Hoare Zoe, Rees Colin J
South Tyneside NHS Foundation Trust, Harton Lane, South Shields, Tyne and Wear, UK.
Wolfson Unit for Endoscopy, St Mark's Hospital, Harrow, Middlesex, UK.
Endosc Int Open. 2016 Feb;4(2):E205-12. doi: 10.1055/s-0041-107900. Epub 2015 Nov 27.
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. A new device called Endocuff Vision™ has been shown to improve adenoma detection rate in pilot studies.
METHODS/DESIGN: This is a prospective, multicenter, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy with standard colonoscopy. All patients above 18 years of age referred for screening, surveillance, or diagnostic colonoscopy who are able to consent are invited to the study. Patients with absolute contraindications to colonoscopy, large bowel obstruction or pseudo-obstruction, colon cancer or polyposis syndromes, colonic strictures, severe diverticular segments, active colitis, anticoagulant therapy, or pregnancy are excluded. Patients are randomized according to site, age, sex, and bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or standard colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Nurse assessment of patient comfort and patient comfort questionnaires are completed post procedure. Patients are followed up at 21 days and complete a patient experience questionnaire. This study will take place across seven NHS Hospital Trusts: one in London and six within the Northern Region Endoscopy Group. A maximum of 10 colonoscopists per site will recruit a total of 1772 patients, with a maximum of four bowel screening colonoscopists permitted per site.
This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ in all screening, surveillance, and diagnostic patient groups. This timely study will guide clinicians as to the role of Endocuff Vision™ in routine colonoscopy.
ISRCTN11821044.
结肠镜检查是诊断肠道病变和进行结直肠癌筛查的金标准检查方法。腺瘤检出率是高质量结肠镜检查的一个指标，高腺瘤检出率与间隔期癌症发病率较低相关。人们已经探索了多种技术进步以提高腺瘤检出率。一种名为Endocuff Vision™的新设备在初步研究中已显示可提高腺瘤检出率。
方法/设计：这是一项前瞻性、多中心、随机对照试验，比较接受Endocuff Vision™辅助结肠镜检查的患者与接受标准结肠镜检查的患者的腺瘤检出率。所有年龄在18岁以上、因筛查、监测或诊断性结肠镜检查而被转诊且能够签署知情同意书的患者均被邀请参加该研究。排除有结肠镜检查绝对禁忌证、大肠梗阻或假性梗阻、结肠癌或息肉病综合征、结肠狭窄、严重憩室段、活动性结肠炎、抗凝治疗或妊娠的患者。患者根据地点、年龄、性别和结直肠癌筛查状态进行随机分组，在检查当天接受Endocuff Vision™辅助结肠镜检查或标准结肠镜检查。收集基线数据、结肠镜检查数据以及包括组织学在内的息肉数据。检查后完成护士对患者舒适度的评估以及患者舒适度问卷。患者在21天进行随访并完成患者体验问卷。本研究将在7个国民保健服务（NHS）医院信托机构进行：1个在伦敦，6个在北部地区内镜检查组内。每个地点最多10名结肠镜检查医师将总共招募1772名患者，每个地点最多允许4名肠道筛查结肠镜检查医师参与。
这是第一项评估Endocuff Vision™在所有筛查、监测和诊断患者群体中腺瘤检出率的试验。这项及时开展的研究将指导临床医生了解Endocuff Vision™在常规结肠镜检查中的作用。
ISRCTN11821044
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