## Protocol Section
### Identification Module
**NCT ID:** NCT06414239

**Acronym:** REVENDO

**Brief Title:** Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask

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

#### Organization Study ID Info
**ID:** APHP220675
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Digestive System Disease

**Keywords:**

- Lower digestive endoscopy whatever the indication

- Digestive endoscopy

- Colonoscopy

- Virtual reality

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized 1:1

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Coloscopy with a virtual reality mask

**Intervention Names:**

- Device: Use of a VR mask

**Label:** Interventional group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Coloscopy without any premedication or anesthesia

**Intervention Names:**

- Other: Standard of care

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional group

**Description:** Virtual reality mask

**Name:** Use of a VR mask

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** Without any premedication or anesthesia

**Name:** Standard of care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Rate of cecal intubation

**Time Frame:** At day 0

#### Secondary Outcomes

**Description:** The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain

**Measure:** Maximum pain assessed by the patient by numerical scale

**Time Frame:** At day 0

**Description:** The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain

**Measure:** Maximum pain assessed by the patient by numerical scale

**Time Frame:** At 1 month

**Description:** The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety

**Measure:** Maximum anxiety assessed by the patient by numerical scale

**Time Frame:** At day 0

**Description:** The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety

**Measure:** Maximum anxiety assessed by the patient by numerical scale

**Time Frame:** At 1 month

**Description:** It will be assesses by the Likert scale

**Measure:** Patient's opinion to repeat the examination under the same conditions

**Time Frame:** At day 0

**Description:** It will be assesses by the Likert scale

**Measure:** Patient's opinion to repeat the examination under the same conditions

**Time Frame:** At 1 month

**Description:** Time between introduction and removal of the colonoscope

**Measure:** Duration of the examination

**Time Frame:** At day 0

**Description:** time between entering and leaving the room

**Measure:** Total duration of the procedure

**Time Frame:** At day 0

**Description:** 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.

**Measure:** Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum

**Time Frame:** At day 0

**Measure:** Proportion of procedures where the VR mask is removed at the patient's request

**Time Frame:** Up to 30 months

**Measure:** Proportion of colonoscopies with detection of at least one adenoma

**Time Frame:** Up to 30 months

**Measure:** Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group

**Time Frame:** Up to 30 months

**Description:** Assessed by the Analogue Visual Scale examination

**Measure:** Operator satisfaction

**Time Frame:** Up to 30 months

**Measure:** Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success

**Time Frame:** Up to 30 months

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mylinh.tranminh@aphp.fr

**Name:** My-Linh TRAN-MINH, Dr

**Phone:** +33142499597

**Role:** CONTACT

**Contact 2:**

**Email:** jerome.lambert@u-paris.fr

**Name:** Jérôme Lambert, Pr

**Phone:** +33142499742

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: HIGH

- As Found: Digestive System Diseases

- ID: M7255

- Name: Digestive System Diseases

- Relevance: HIGH

- As Found: Digestive System Diseases

### Condition Browse Module - Meshes

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
