跳至主要内容
临床试验/NCT03420612
NCT03420612已完成不适用

A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 607 人开始时间: 2017年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
607
试验地点
1
主要终点
risk factor associated with painful colonoscopy rate

研究概览

简要总结

Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-80 years
  • underwent unsedated colonoscopy

排除标准

  • no bowel preparation or colon cleansing by enema only
  • no need to reach cecum
  • prior finding of severe colon stenosis or obstructing tumor
  • history of colectomy
  • unstable hemodynamics
  • unable to give informed consent.

结局指标

主要结局

risk factor associated with painful colonoscopy rate

时间窗: 2 hours

Abdominal pain during the examination was evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)\[14\], and moderate or severe pain during the procedure was defined as a "painful colonoscopy"

次要结局

未报告次要终点

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (1)

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