Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not. (RMR)

Institut Paoli-Calmettes

Status: Not yet enrolling

Conditions: Breast Reconstruction; Mastectomy

Treatments: Procedure: Not robot-assisted surgery; Device: Robot-assisted

Study type: Interventional

Funder types: Other

Identifiers

NCT04457167

RMR-IPC 2017-039

2020-A01644-35 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 480 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old,
2. Signed consent to participate,
3. Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
4. Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
5. Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
6. immediate breast reconstruction by autologous latissimus dorsi flap
7. immediate breast reconstruction by latissimus dorsi flap and prosthesis,
8. secondary breast reconstruction by latissimus dorsi flap
9. Affiliation to, or beneficiary of, a social security scheme.

Exclusion criteria

1. Patient under 18,
2. Pregnant woman or likely to be (without effective contraception) or breastfeeding,
3. Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
4. Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

480 participants in 2 patient groups

Robotic surgery

Experimental group

Description:

Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,

Treatment:

Device: Robot-assisted

Non robotic surgery

Active Comparator group

Description:

Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,

Treatment:

Procedure: Not robot-assisted surgery