Recruitment

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