Clinical trial NCT04343820: Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Official title: Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Female
Keywords: reconstruction
lipo-modelling
breast cancer
mastectomy
prepectoral implant
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.

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.

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

Primary outcomes:
measure: Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the aesthetic result
timeFrame: 6 months, 12 months and 24 months
measure: Evaluate the quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Victoire BRILLAUD-MEFLAH, MD
role: PRINCIPAL_INVESTIGATOR
References: