Clinical trial NCT04457167: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mastectomy
Breast Reconstruction
Keywords: robot-assisted
mini-invasive surgery
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Phase III, non-randomized, monocentric, observational, prospective trial.
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: rate of postoperative early complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gilles Houvenaeghel
role: PRINCIPAL_INVESTIGATOR
References: