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

Not Applicable

Recruiting

• Conditions: Adenomyoma of Uterus; Myoma;Uterus
• Interventions: Device: Laparoscopic surgery with augmented reality device

• Registration Number: NCT06067971
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-05-16
• Study Completion: 2025-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery with the augmented reality device	Laparoscopic surgery with augmented reality device	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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 laparoscopic/laparotomy conversions	In the intra-operative phase of the study	Collection of the number of laparoscopic/laparotomy conversions.
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.
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
Quantification of bleeding	In the intra-operative phase of the study	Collection of bleeding volume during the surgery.
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.
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.

Trial Locations

Locations (3)

Polyclinique Urbain V; 🇫🇷 Avignon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Saint-Étienne; 🇫🇷 Saint-Étienne, France