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The Clinical Acceptability of Unsedated Colonoscopy

2011年9月13日 更新者:Franco Radaelli、Valduce Hospital

Unsedated Colonoscopy: An Option For Some But Not For All

The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.

研究概览

详细说明

Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.

研究类型

观察性的

注册 (实际的)

964

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

      • Como、意大利、22100
        • Vadluce Hospital

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 80年 (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

all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.

描述

Inclusion Criteria:

  • adult outpatients

Exclusion Criteria:

  1. previous colorectal surgery
  2. indication to a bi-directional endoscopy
  3. indication to a partial examination
  4. patients' refusal or inability to provide informed consent and
  5. advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)

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

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Colonoscopy outpatients
All patients referred to our Unit to undergo colonoscopy for any indication
Patients were offered to undergo colonoscopy without routine premedication
Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded

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
ODDS ratio for unsedated colonoscopy acceptance
大体时间:up to 8 months
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the acceptance of unsedated colonoscopy
up to 8 months

次要结果测量

结果测量
措施说明
大体时间
Acceptance rate of unsedated colonoscopy
大体时间:up to 8 months
Proportion of patients accepting to attempt colonoscopy without routine premedication
up to 8 months
ODDS ratios for unsedated colonoscopy completion
大体时间:up to 8 months
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the completion of unsedated colonoscopy
up to 8 months

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:Franco Radaelli, MD、Valduce Hospital

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

2009年10月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2011年8月18日

首先提交符合 QC 标准的

2011年9月13日

首次发布 (估计)

2011年9月15日

研究记录更新

最后更新发布 (估计)

2011年9月15日

上次提交的符合 QC 标准的更新

2011年9月13日

最后验证

2011年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 07CE2009

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