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

February 12, 2026 updated by: Institut Cancerologie de l'Ouest

Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 women who have had a mastectomy and want a secondary breast reconstruction by implant at Institut de Cancérologie de l'Ouest well be included in this study.

Patients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy.

They will be followed for 24 months from the end of the breast reconstruction.

The following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) :

  • Clinical data
  • Technique-related data
  • Complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction
  • Aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction
  • Quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction

Clinicians at Institut de Cancérologie de l'Ouest may be asked to complete the previous informations.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Herblain, France, 44805
        • Institut de Cancerologie de L'Ouest Rene Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast reconstruction
Women who have had a mastectomy and want a secondary breast reconstruction by implant.
Procedure: Breast reconstruction
Breast reconstruction by prepectoral positioned implant after lipo-preparation of the wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
Time Frame: 12 months
Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the aesthetic result
Time Frame: 6 months, 12 months and 24 months
Aesthetic result will be assessed by giving a mark from 0 to 5 for the following categories : general breast appearance ; breast curve ; breast consistency ; breast volume Both clinician and patient will complete the evaluation.
6 months, 12 months and 24 months
Evaluate the quality of life
Time Frame: 24 months
Patient satisfaction and quality of life will be assessed from Breast Q. The evaluation criteria will be the Breast Q score 24 months after the intervention.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Victoire BRILLAUD-MEFLAH, MD, Institut de cancerologie de l'ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2019

Primary Completion (Actual)

January 7, 2025

Study Completion (Actual)

January 7, 2025

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-N-2018-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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