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临床试验/NCT04093557
NCT04093557撤回不适用

Validation of a Novel Clinical Prediction Scoring System for Improved Bowel Preparation Prior to Outpatient Colonoscopy

University of Virginia2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
500
试验地点
2
主要终点
Inadequate prep rate

研究概览

简要总结

Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology & Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals.

Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection.

The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older (up to 100 years)
  • Referred for open access colonoscopy from an outside provider/UVA provider
  • Able to provide informed consent

排除标准

  • Prisoners

结局指标

主要结局

Inadequate prep rate

时间窗: Through study duration, approximately 1 year

Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance)

次要结局

  • Polyp burden(Through study duration, approximately 1 year)
  • Adenoma detection rate (ADR)(Through study duration, approximately 1 year)
  • Advanced adenoma / adenocarcinoma detection rate(Through study duration, approximately 1 year)
  • Incomplete colonoscopy rate(Through study duration, approximately 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Powell, MD

Associate Professor

University of Virginia

研究点 (2)

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