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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01644-35 | Other Identifier | ANSM |
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Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic surgery | Experimental | Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, |
|
| Non robotic surgery | Active Comparator | Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted | Device | robot-assisted surgery |
| |
| Not robot-assisted surgery |
| Measure | Description | Time Frame |
|---|---|---|
| rate of postoperative early complications | To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Genre | Contact | 33491223778 | DRCI.UP@ipc.unicancer.fr | |
| Margot Berline | Contact | 33491223778 | DRCI.UP@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gilles Houvenaeghel | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli-Calmettes | Marseille | 13009 | France |
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Phase III, non-randomized, monocentric, observational, prospective trial.
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| Procedure |
Not robot-assisted surgery |
|
| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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