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.

Breast Reconstruction Clinical Trial

— RMR  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04457167
• Other study ID #: RMR-IPC 2017-039
• Secondary ID: 2020-A01644-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2026

Study information

• Verified date: June 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre
• Phone: 33491223778
• Email: DRCI.UP[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reconstruction
• Mastectomy

Intervention

Device:
• Robot-assisted
robot-assisted surgery

Procedure:
• Not robot-assisted surgery
Not robot-assisted surgery

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of postoperative early complications	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)	90 days