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临床试验/NCT05051046
NCT05051046招募中不适用

Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial

University Hospital, Tours2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Rate of complete colonoscopies

研究概览

简要总结

Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated

详细描述

Colorectal cancer is the 3rd most common cancer. Colonoscopy, a screening examination, has led to an increase in patient survival. In more than 90% of cases, this examination is performed under general anesthesia (GA) because it is considered painful, even though several studies have shown its feasibility without GA with a good tolerance in 75% of cases. However, only 28% of patients accept the examination without GA because of great apprehension. GA entails an increased risk of complications but also additional costs. Thus, performing colonoscopies without GA would reduce risks and costs by 15 to 30%. In order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. To date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized.

The use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to GA and reduce the organizational constraints and costs related to GA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients 18 years of age or older
  • •Undergoing a screening colonoscopy (mass screening Fecal Immunochemical Test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia
  • •Affiliated with a French social security system
  • •Having signed a written consent

排除标准

  • •Patient requiring emergency colonoscopy
  • •History of colonic resection
  • •Carriers of behavioral disorders and/or psychiatric illness
  • •Limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems)
  • •Contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment)
  • •Contraindication to general anesthesia
  • •Under a legal protection regime
  • •Pregnant or breastfeeding woman

研究组 & 干预措施

Hypnosis

Experimental

干预措施: Colonoscopy under hypnosis (Procedure)

General anesthesia

No Intervention

Common practice

结局指标

主要结局

Rate of complete colonoscopies

时间窗: The day of the colonoscopy, from the start to the end of the colonoscopy

Rate of complete colonoscopies: a colonoscopy is said to be complete when the endoscopist visualizes the caecal fundus.

次要结局

  • Duration of colonoscopy(The day of colonoscopy from the start to the end of the exam)
  • Level of anxiety(The day of the colonoscopy, before the exam)
  • Level of pain(Up to 24 hours the day of colonoscopy)
  • Rate of complications(To the day of the exam to 8 days after)
  • Rate of polyps resected(The day of colonoscopy from the start to the end of the exam)
  • Patient satisfaction(Up to 24 hours the day of the colonoscopy)
  • Medico economic criteria(To the day of the exam to 3 months after)
  • Level of pain(During the consultation before the colonoscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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