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

NCT ID: NCT04343820

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-24
• Study Completion Date: 2024-12-24

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.

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.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast reconstruction

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

Breast reconstruction

Intervention Type: PROCEDURE

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

Interventions

Breast reconstruction

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoire BRILLAUD-MEFLAH, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-N-2018-15

Identifier Type: -

Identifier Source: org_study_id