Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 foll...
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.
Tracking Information
- NCT #
- NCT04343820
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Victoire BRILLAUD-MEFLAH, MD Institut de Cancérologie de l'Ouest