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Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy (REPREP)

2020年12月31日 更新者:Lorenzo Fuccio、IRCCS Azienda Ospedaliero-Universitaria di Bologna

Factors Related to a Persistent Inadequate Bowel Preparation After a Colonoscopy With Inadequate Colon Cleansing. An Observational Prospective Multicenter Study

Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again.

Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units.

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

  • Emergency regime
  • Inability to obtain consent
  • Refusal of the patient

Primary end-point:

Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model.

The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments.

Secondary end-point:

• Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

407

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • BO
      • Bologna、BO、意大利、40138
        • 招聘中
        • UOC Gastroenterologia ed Endoscopia Digestiva
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Outpatient and hospitalized adult patients, candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

描述

Inclusion Criteria:

  • Outpatients or hospitalized patients
  • adults
  • candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

Exclusion Criteria:

  • Emergency regimen
  • Inability to obtain consent
  • Patient refusal

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Study cohort

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

  • Emergency regime
  • Inability to obtain consent
  • Refusal of the patient
A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Identification of factors related to persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
大体时间:Outcome will be assessed during colonoscopy.
A logistic regression analysis will be run to identify such factors.
Outcome will be assessed during colonoscopy.

次要结果测量

结果测量
措施说明
大体时间
Prevalence of persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
大体时间:Outcome will be assessed during colonoscopy.
The prevalence of inadequate colon cleansing at repeat colonoscopy will be assessed
Outcome will be assessed during colonoscopy.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月1日

初级完成 (预期的)

2021年5月1日

研究完成 (预期的)

2021年6月1日

研究注册日期

首次提交

2020年12月29日

首先提交符合 QC 标准的

2020年12月31日

首次发布 (实际的)

2021年1月5日

研究记录更新

最后更新发布 (实际的)

2021年1月5日

上次提交的符合 QC 标准的更新

2020年12月31日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • REPREP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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