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Colonoscopy in the Prone Position for Patients With BMI Greater Than 30

2019年6月10日 更新者:Brooke Corning、University of Virginia

Colonoscopy in the Prone Position for Patients With BMI Greater Than 30 Is Superior to Standard Left Lateral Decubitus Position

In the United States, colonoscopy has become the most commonly used screening test for colorectal cancer. Colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians.

The investigators plan to randomize patients with Body Mass Index >30 that are presenting to the University of Virginia for colonoscopy to either the prone or left lateral decubitus position. The investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.

研究概览

地位

完全的

条件

详细说明

Patients that have been scheduled for colonoscopy will undergo chart review. Patients who meet inclusion criteria will be invited to participate at the time consent is obtained for the colonoscopy. Participants will then be randomized to one of two colonoscopy starting positions.

After randomization, patients will begin the colonoscopy in either the prone position or left lateral decubitus position.

It is common practice to re-position the patient during endoscopy (including supine and prone positions) and some endoscopists commonly employ prone starting position for obese patients, although there is no estimate in the literature as to the prevalence of this practice.

No additional interventions will be performed for research purposes. During the colonoscopy, the endoscopist will be allowed, as usual, to adjust patient position as needed to complete the procedure. Cecal intubation time, amount of sedation used, and any intra-procedural complications (hypoxia, hypotension, etc) will be recorded for data analysis. This information is standardly recorded in the procedure report in the patient's medical record. The study will not affect any interventions performed during the colonoscopy such as polyp removal or biopsies as, clinically indicated. Per endoscopy unit protocol, patients will be monitored in the recovery area and discharged home with supervision. The study requires no further direct patient interaction after the colonoscopy is completed. Charts will be reviewed at 30 days to assess for any delayed and unexpected complications.

研究类型

介入性

注册 (实际的)

141

阶段

  • 不适用

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

    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia

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 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI >30
  • Undergoing screening or diagnostic colonoscopy with conscious sedation

Exclusion Criteria:

  • Pregnant women (self reported).
  • Cognitively impaired patients
  • History of colonic resection
  • Cannot lay in prone position
  • History of colon malignancy
  • Procedure aborted due to inadequate bowel prep
  • Severe pulmonary problems (including baseline oxygen use)
  • Inability to provide consent for themselves

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

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Prone Position
Position during colonoscopy
Position during colonoscopy
有源比较器:Left lateral decubitus position
Position during colonoscopy
Position during colonoscopy

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
Cecal intubation time measured in seconds
大体时间:Measured once during colonoscopy.
Time to advance the colonoscope to the cecum during colonoscopy.
Measured once during colonoscopy.

次要结果测量

结果测量
措施说明
大体时间
Milligrams of sedative used for sedation
大体时间:Measured once at the completion of the colonoscopy.
Amount of fentanyl and midazolam needed for adequate sedation.
Measured once at the completion of the colonoscopy.
Technical difficulty of procedure (questionnaire)
大体时间:Recorded once at the completion of the colonoscopy.
Measure of subjective sense of difficulty as perceived by the endoscopist.
Recorded once at the completion of the 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。

调查人员

  • 首席研究员:Brooke Corning, MD、University of Virginia, Dept of Internal Medicine, Divison of Gastroenterology and Hepatology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2017年12月10日

初级完成 (实际的)

2019年6月10日

研究完成 (实际的)

2019年6月10日

研究注册日期

首次提交

2017年11月6日

首先提交符合 QC 标准的

2017年11月6日

首次发布 (实际的)

2017年11月8日

研究记录更新

最后更新发布 (实际的)

2019年6月12日

上次提交的符合 QC 标准的更新

2019年6月10日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 20078

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Position during colonoscopy的临床试验

3
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