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NCT Number: NCT04343820

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, 44805, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Breast reconstruction

Procedure

Breast reconstruction by prepectoral positioned implant after lipo-preparation of the wall.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: RM2prepec

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2020
Registry last updated
Feb 17, 2026

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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