Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Rate of cecal intubation
研究概览
简要总结
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 of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.
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
- •Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
排除标准
- •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
结局指标
主要结局
Rate of cecal intubation
时间窗: At day 0
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
次要结局
- Maximum anxiety assessed by the patient by numerical scale(At 1 month)
- Maximum pain assessed by the patient by numerical scale(At 1 month)
- Duration of the examination(At day 0)
- Total duration of the procedure(At day 0)
- Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum(At day 0)
- Proportion of procedures where the VR mask is removed at the patient's request(Up to 30 months)
- Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group(Up to 30 months)
- Patient's opinion to repeat the examination under the same conditions(At 1 month)
- Proportion of colonoscopies with detection of at least one adenoma(Up to 30 months)
- Operator satisfaction(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)