Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01987-34 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery with the augmented reality device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic surgery with augmented reality device | Device | Gynecological laparoscopic surgery with augmented reality device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | In the intra-operative phase of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In the intra-operative phase of the study |
| Collection of operative time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pauline CHAUVET | pchauvet@chu-clermontferrand.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Urbain V | Avignon | France | ||||
| CHU Clermont-Ferrand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.
| 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) | 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 | 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. | 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. | 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). | 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. | In the intra-operative phase of the study |
| Clermont-Ferrand |
| France |
| CHU de Saint-Étienne | Saint-Etienne | France |
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided