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.

Not Applicable

Not yet recruiting

• Conditions: Mastectomy; Breast Reconstruction
• Interventions: Device: Robot-assisted; Procedure: Not robot-assisted surgery

• Registration Number: NCT04457167
• Lead Sponsor: Institut Paoli-Calmettes

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Study Start: 2020-11-01
• Primary Completion: 2023-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic surgery	Robot-assisted	Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,
Non robotic surgery	Not robot-assisted surgery	Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France