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

Breast Cancer Female Clinical Trial

— RM2prepec  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04343820
• Other study ID #: ICO-N-2018-15
• Status: Active, not recruiting
• Start date: December 24, 2019
• Est. completion date: December 24, 2024

Study information

• Verified date: August 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 24, 2024
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest René Gauducheau	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the aesthetic result	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
Secondary	Evaluate the quality of life	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