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

University Hospital, Clermont-Ferrand3 sites in 1 country40 target enrollmentMarch 29, 2023

ConditionsMyoma;Uterus Adenomyoma of Uterus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myoma;Uterus
Sponsor: University Hospital, Clermont-Ferrand
Enrollment: 40
Locations: 3
Primary Endpoint: The feasibility of augmented reality will be measure using the SURG-TLX scale
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 29, 2023

End Date

May 15, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University Hospital, Clermont-Ferrand

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

The feasibility of augmented reality will be measure using the SURG-TLX scale

Time Frame: 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 Outcomes

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)
Number of device failures during surgery(In the intra-operative phase of the study)
Number of laparoscopic/laparotomy conversions(In the intra-operative phase of the study)
Score of the surgeon's performance in using the augmented reality device(In the intra-operative phase of the study)
Number of failures to start up the software(In the intra-operative phase of the study)
Quantification of bleeding(In the intra-operative phase of the study)
Collection of operative time(In the intra-operative phase of the study)
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)