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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT06067971

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

13.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma;Uterus Adenomyoma of Uterus	Device: Laparoscopic surgery with augmented reality device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 29, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Mar 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic surgery with the augmented reality device	Device: Laparoscopic surgery with augmented reality device Gynecological laparoscopic surgery with augmented reality device.

Arm

Intervention/Treatment

Experimental: Laparoscopic surgery with the augmented reality device

Device: Laparoscopic surgery with augmented reality device

Gynecological laparoscopic surgery with augmented reality device.

Outcome Measures

Primary Outcome Measures

The feasibility of augmented reality will be measure using the SURG-TLX scale [In the intra-operative phase of the study]
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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 84 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).