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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted, Not robot-assisted surgery.
- Who it may be relevant to
- Registry conditions: Mastectomy, Breast Reconstruction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device Robot-assisted
robot-assisted surgery - Procedure Not robot-assisted surgery
Not robot-assisted surgery
Primary outcome measures
- rate of postoperative early complications [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old,
- Signed consent to participate,
- Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
- Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
- Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
- immediate breast reconstruction by autologous latissimus dorsi flap
- immediate breast reconstruction by latissimus dorsi flap and prosthesis,
- secondary breast reconstruction by latissimus dorsi flap
- Affiliation to, or beneficiary of, a social security scheme.
Exclusion criteria
- Patient under 18,
- Pregnant woman or likely to be (without effective contraception) or breastfeeding,
- 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,
- Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Institut Paoli-Calmettes — Marseille
Identifiers
NCT: NCT04457167 · RMR-IPC 2017-039 · 2020-A01644-35