CompletedNot Applicable

Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)

France60 participantsStarted 2019-12-24

Plain-language summary

Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes. The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session. For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients. The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization). The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Woman aged over 18 * Medical history of mastectomy +/- radiotherapy * Woman requesting breast reconstruction by implant * Patient treated for non-metastatic cancer Exclusion Criteria: * Locally uncontrolled disease * Metastatic disease * Patient with major cutaneous atrophy allowing only flap reconstruction * Patients under guardianship or trusteeship * Patients who objected to the research

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Describe the complications that occurs after a prepectoral placed implant with lipo-preparation

Timeframe: 12 months

Trial details

NCT IDNCT04343820

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-07

View on ClinicalTrials.gov More Breast Cancer Female trials