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临床试验/NCT06521658
NCT06521658已完成不适用

Reduction of Pain in Colonoscopy - Loop First Versus Last

Esbjerg Hospital - University Hospital of Southern Denmark4 个研究点 分布在 1 个国家目标入组 1,120 人开始时间: 2024年9月23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
1,120
试验地点
4
主要终点
Remembrance of pain

研究概览

简要总结

Colonoscopy is an endoscopic examination of the colon. Colonoscopy is used to investigate medical gastroenterological diseases, as well as to investigate suspected cancer and to prevent it by identifying and removing premalignant changes - polyps (e.g., as part of the national screening program for colorectal cancer).

As part of a normal endoscopic examination, the tip of the endoscope is bent (retroflexed) to look "backward" into the rectum. This is done to better see the inside of the rectal opening. Performing such a retroflexion of the scope is often associated with discomfort/pain for the patient. It takes 5-10 seconds. There are no guidelines on when such a retroflexion should be done - at the beginning or at the end of the procedure. The aim is to investigate whether the timing of retroflexion makes a difference in the recollection of pain following the procedure. In this way, the pain of colonoscopy might be reduced in the future simply by changing the timing of the retroflexion.

The study is solely about performing this retroflexion either at the beginning or at the end of the examination. Nothing is changed in the diagnostic part of the examination.

The background of the study is a study from 2003 that shows that taking about a one-minute pause in the rectum at the end of the colonoscopy can reduce the overall pain perception of the examination. This was shown without changing the pain during the procedure and despite the fact that the examination itself was prolonged due to the intervention. This relationship is explained by studies showing that the pain experience at the end of a procedure has a greater influence than the pain experience at the beginning of a procedure on the overall pain experience.

Hypothesis: By retroflexing in the rectum first during a colonoscopy versus at the end, patients will perceive the overall procedure as less painful.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Only the doctor and nurses performing the colonoscopy will not be masked to the intervention

入排标准

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

入选标准

  • Patients scheduled for elective diagnostic colonoscopy at the surgical department

排除标准

  • pregnancy
  • colonoscopy under general anæsthesia
  • patients not fluent in danish
  • patients uanable to understand the study (e.g. people with diagnosed or suspected dementia)

结局指标

主要结局

Remembrance of pain

时间窗: 15-60 minutes post colonoscopy

Visual Analogue Pain (VAS) score of pain. The score is from 0-100 where a smaller score means less pain.

次要结局

  • Maximal pain(15-60 minutes post colonoscopy)

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Sponsor

研究点 (4)

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