International Prospective REgistry on Pre-pectorAl Breast REconstruction
- Conditions
- Breast Cancer
- Registration Number
- NCT05817175
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
- Detailed Description
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1236
- Female patients older than 18 years old
- Signed informed consent form
- Patients undergoing mono or bilateral therapeutic mastectomy
- Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with Implant-loss at three months postoperatively three months postoperatively Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
- Secondary Outcome Measures
Name Time Method Number of Early onset complication three months postoperatively Early onset complication at 3 month follow up: seroma, hematoma/bleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome
Number of late-onset complications 6-12-24 months seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;
Number of patients with Infection three months postoperatively Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
Number of patients with re-admission and re-operation three months postoperatively Rate of re-admission and re-operation
Evaluation of Quality of life 0, 6, 12 and 24 months Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)
Trial Locations
- Locations (11)
Univesidad de Buenos Aires
🇦🇷Buenos Aires, Argentina
Mansoura Insurance
🇪🇬Mansoura, Egypt
Mansoura Oncology
🇪🇬Mansoura, Egypt
National ans Kapodistrian University of Athens
🇬🇷Athens, Greece
Ospedale San Raffaele
🇮🇹Milano, MI, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, RM, Italy
University Hospital of Karol Marcinkowski
🇵🇱Zielona Góra, Poland
Prof. Dr. Ion Chiricuta Institute of Oncology
🇷🇴Cluj-Napoca, Romania
Hospital del Mar
🇪🇸Barcelona, Spain
Marmara University School of medicine
🇹🇷Istanbul, Turkey
University Hospitals of Leicester
🇬🇧Leicester, United Kingdom