Clinical trial NCT06067971: Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)
Official title: Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myoma;Uterus
Adenomyoma of Uterus
Keywords: Augmented Reality
Laparoscopic surgery
Uterine myomectomy
Uterine adenomyomectomy
Hysterectomy
Minimally invasive surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: The feasibility of augmented reality will be measure using the SURG-TLX scale
timeFrame: In the intra-operative phase of the study
Secondary outcomes:
measure: Score of the surgeon's performance in using the augmented reality device
timeFrame: In the intra-operative phase of the study
measure: Collection of operative time
timeFrame: In the intra-operative phase of the study
measure: Number of device failures during surgery
timeFrame: In the intra-operative phase of the study
measure: Number of failures to start up the software
timeFrame: In the intra-operative phase of the study
measure: Collection of the real direct medical costs of the procedure from an institutional point of view.
timeFrame: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
measure: Number of laparoscopic/laparotomy conversions
timeFrame: In the intra-operative phase of the study
measure: Number of intraoperative and postoperative complications
timeFrame: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
measure: Quantification of bleeding
timeFrame: In the intra-operative phase of the study
Other outcomes:
Locations:
city: Avignon
country: France
facility: Polyclinique Urbain V
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Saint-Étienne
country: France
facility: CHU de Saint-Étienne
Study officials:
affiliation: pchauvet@chu-clermontferrand.fr
name: Pauline CHAUVET
role: PRINCIPAL_INVESTIGATOR
References: