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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Gynecological laparoscopic surgery with augmented reality device.
Polyclinique Urbain V
Avignon, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU de Saint-Étienne
Saint-Etienne, France
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).
Time frame: In the intra-operative phase of the study
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: In the intra-operative phase of the study
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