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临床试验 NCT06414239 (REVENDO) 针对消化系统疾病目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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大巴黎大学医院无麻醉下改善下消化道内镜检查：虚拟现实面罩评估 (REVENDO) 240 虚拟
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临床试验NCT06414239 (REVENDO)是一项针对消化系统疾病的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2024年6月1日开始，预计招募240名患者。该研究由大巴黎大学医院主导，计划于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年5月16日。
简要概括
90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience ...显示更多
官方标题
Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
疾病
消化系统疾病其他研究标识符
- REVENDO
- APHP220675
NCT编号
实际开始日期
2024-06
最近更新发布
2024-05-16
预计完成日期
2026-12
计划入组人数
240
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Lower digestive endoscopy whatever the indication
Digestive endoscopy
Colonoscopy
Virtual reality
Digestive endoscopy
Colonoscopy
Virtual reality
主要目的
诊断
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Interventional group Coloscopy with a virtual reality mask | Use of a VR mask Virtual reality mask |
其他Control group Coloscopy without any premedication or anesthesia | 标准护理 Without any premedication or anesthesia |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rate of cecal intubation | Success of a total colonoscopy defined by the rate of cecal intubation (visualization of the ileocecal valve and the appendicular orifice with the endoscope located near the appendicular orifice) or visualization of the ileocecal anastomosis in case of history of surgery removing the ileocaecal valve | At day 0 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Maximum pain assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain | At day 0 |
Maximum pain assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain | At 1 month |
Maximum anxiety assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety | At day 0 |
Maximum anxiety assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety | At 1 month |
Patient's opinion to repeat the examination under the same conditions | It will be assesses by the Likert scale | At day 0 |
Patient's opinion to repeat the examination under the same conditions | It will be assesses by the Likert scale | At 1 month |
Duration of the examination | Time between introduction and removal of the colonoscope | At day 0 |
Total duration of the procedure | time between entering and leaving the room | At day 0 |
Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum | Between the introduction of the colonoscope and 30 minutes maximum. It can be the ileum in the event of a history of surgery removing the valve. | At day 0 |
Proportion of procedures where the VR mask is removed at the patient's request | Up to 30 months | |
Proportion of colonoscopies with detection of at least one adenoma | Up to 30 months | |
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group | Up to 30 months | |
Operator satisfaction | Assessed by the Analogue Visual Scale examination | Up to 30 months |
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success | Up to 30 months |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
- Hearing problems or low vision
- Psychiatric or cognitive disorders hindering communication
- History of epilepsy
- Claustrophobia which can lead to a rejection of the virtual reality mask
- History of cybercynetosis during previous use of VR
- Chronic abdominal pain with baseline Visual analogue scale (VAS) > 5
- Emergency examination
- Patient participating in another interventional research on digestive endoscopy
- Patient not speaking French
- Patient under guardianship
大巴黎大学医院967 个活跃的临床试验可供探索研究中心联系人
联系人: My-Linh TRAN-MINH, Dr, +33142499597, [email protected]
联系人: Jérôme Lambert, Pr, +33142499742, [email protected]
没有位置数据。