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NCT Number: NCT04457167

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot-assisted

Device

robot-assisted surgery

Not robot-assisted surgery

Procedure

Not robot-assisted surgery

Primary outcomes

  1. rate of postoperative early complications

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Genre

CONTACT

[email protected]

33491223778

Margot Berline

CONTACT

[email protected]

33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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.

Acronym: RMR

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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