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.

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04457167

Acronym

RMR

Enrollment

480

Registered

2020-07-07

Start date

2020-11-01

Completion date

2026-11-01

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction, Mastectomy

Keywords

robot-assisted, mini-invasive surgery

Brief summary

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.

Detailed description

Interventions

DEVICERobot-assisted

robot-assisted surgery

PROCEDURENot robot-assisted surgery

Not robot-assisted surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Phase III, non-randomized, monocentric, observational, prospective trial.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
rate of postoperative early complications	90 days	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)

Countries

France

Contacts

Primary ContactDominique Genre

DRCI.UP@ipc.unicancer.fr33491223778

Backup ContactMargot Berline