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

NCT04343820 | Completed

• 1 other identifier: ICO-N-2018-15
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Female

Keywords

reconstruction; lipo-modelling; breast cancer; mastectomy; prepectoral implant

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Evaluate the aesthetic result

  6 months, 12 months and 24 months

• Evaluate the quality of life

  24 months

Study Arms (1)

Breast reconstruction

Women who have had a mastectomy and want a secondary breast reconstruction by implant.

Procedure: Breast reconstruction

Interventions

Breast reconstruction PROCEDURE

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

Breast reconstruction

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Woman aged over 18
• Medical history of mastectomy +/- radiotherapy
• Woman requesting breast reconstruction by implant
• Patient treated for non-metastatic cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Victoire BRILLAUD-MEFLAH, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 13, 2020
• Study Start: December 24, 2019
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)