Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)

Study Overview
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Brief Summary
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Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.

Official Title
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Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.

Conditions
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Myoma;Uterus, Adenomyoma of Uterus

Intervention / Treatment
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* Device: Laparoscopic surgery with augmented reality device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 (included) and 84 (included), Patient with intrauterine myoma, with indication for surgical management by laparoscopic myomectomy, or uterine pathology with indication for surgical management by laparoscopic hysterectomy, Patient affiliated or beneficiary of a health insurance scheme, Patient agreeing to participate in the study after having received the written information document and signed the consent form. Exclusion Criteria: Patients under 18 or over 84 years of age, Patients with contraindications to MRI (pacemaker, ocular metal splinters, etc.), Impossibility of planned surgery, Patient with endometrial cancer contraindicating laparoscopic surgery, Known pregnant or breast-feeding patient, Patient of legal age, under guardianship or curatorship, Patients whose regular follow-up is impossible for geographical, psychological, family or social reasons (these reasons will be collected).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic surgery with the augmented reality device<br> | Device: Laparoscopic surgery with augmented reality device<br>* Gynecological laparoscopic surgery with augmented reality device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of augmented reality will be measure using the SURG-TLX scale | The feasibility of the technique will be considered satisfactory if the SURG-TLX score given by the surgeon at the end of the procedure is less than or equal to 33.7 (threshold defined by experts). | In the intra-operative phase of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the surgeon's performance in using the augmented reality device | Measuring the performance-related score when using the augmented reality device by filling in a scale. | In the intra-operative phase of the study | 
| Collection of operative time | Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation. | In the intra-operative phase of the study | 
| Number of device failures during surgery | Number of device failures during surgery (defined as an abrupt stop of the device during its use) | In the intra-operative phase of the study | 
| Number of failures to start up the software | Collection of the number of failures to set up the augmented reality device | In the intra-operative phase of the study | 
| Collection of the real direct medical costs of the procedure from an institutional point of view. | Collection of the real direct medical costs of the procedure from an institutional point of view. | From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery | 
| Number of laparoscopic/laparotomy conversions | Collection of the number of laparoscopic/laparotomy conversions. | In the intra-operative phase of the study | 
| Number of intraoperative and postoperative complications | Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds). | From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery | 
| Quantification of bleeding | Collection of bleeding volume during the surgery. | In the intra-operative phase of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy, Minimally invasive surgery