Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask (REVENDO)

Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Digestive System Disease
• Intervention / Treatment: Device: Use of a VR mask; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, Pr; Phone Number: +33142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: My-Linh TRAN-MINH, Dr; Phone Number: +33142499597; Email: mylinh.tranminh@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Coloscopy with a virtual reality mask	Device: Use of a VR mask; Virtual reality mask
Other: Control group; Coloscopy without any premedication or anesthesia	Other: Standard of care; Without any premedication or anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Colonoscopy; Virtual reality; Digestive endoscopy; Lower digestive endoscopy whatever the indication
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: APHP220675

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No