Digestive System Disease
Conditions
Keywords
Lower digestive endoscopy whatever the indication, Digestive endoscopy, Colonoscopy, Virtual reality
Brief summary
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.
Interventions
DEVICEUse of a VR mask
Virtual reality mask
OTHERStandard of care
Without any premedication or anesthesia
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of cecal intubation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain assessed by the patient by numerical scale | At day 0 | The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain |
| Maximum anxiety assessed by the patient by numerical scale | At day 0 | The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety |
| Patient's opinion to repeat the examination under the same conditions | At day 0 | It will be assesses by the Likert scale |
| Duration of the examination | At day 0 | Time between introduction and removal of the colonoscope |
| Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum | At day 0 | 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. |
| Total duration of the procedure | At day 0 | time between entering and leaving the room |
| 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 | Up to 30 months | Assessed by the Analogue Visual Scale examination |
| Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success | Up to 30 months | — |
| Proportion of procedures where the VR mask is removed at the patient's request | Up to 30 months | — |
Contacts
Primary ContactMy-Linh TRAN-MINH, Dr
Backup ContactJérôme Lambert, Pr
Outcome results
None listed