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.

NCT04457167 | Not Yet Recruiting FDA Device

• 2 other identifiers: RMR-IPC 2017-0392020-A01644-35
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Breast Reconstruction

Keywords

robot-assisted; mini-invasive surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Robotic surgery

EXPERIMENTAL

Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,

Device: Robot-assisted

Non robotic surgery

ACTIVE COMPARATOR

Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,

Procedure: Not robot-assisted surgery

Interventions

Robot-assisted DEVICE

robot-assisted surgery

Robotic surgery

Not robot-assisted surgery PROCEDURE

Not robot-assisted surgery

Non robotic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Gilles Houvenaeghel

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Genre

CONTACT

33491223778; DRCI.UP@ipc.unicancer.fr

Margot Berline

CONTACT

33491223778; DRCI.UP@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, non-randomized, monocentric, observational, prospective trial.

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)