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.
NCT ID: NCT04457167
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
480 participants
INTERVENTIONAL
2020-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic surgery
Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,
Robot-assisted
robot-assisted surgery
Non robotic surgery
Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,
Not robot-assisted surgery
Not robot-assisted surgery
Interventions
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Robot-assisted
robot-assisted surgery
Not robot-assisted surgery
Not robot-assisted surgery
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Gilles Houvenaeghel
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Institut Paoli-Calmettes
Marseille, , France
Countries
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Central Contacts
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Other Identifiers
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2020-A01644-35
Identifier Type: OTHER
Identifier Source: secondary_id
RMR-IPC 2017-039
Identifier Type: -
Identifier Source: org_study_id
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