International Prospective REgistry on Pre-pectorAl Breast REconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pre-pectoral breast reconstruction.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Egypt, Greece, Italy, Poland +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure pre-pectoral breast reconstruction
to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy
Primary outcome measures
- Number of patients with Implant-loss at three months postoperatively [Time frame: three months postoperatively]
Secondary outcome measures (5)
- Number of patients with Infection [Time frame: three months postoperatively]
- Number of patients with re-admission and re-operation [Time frame: three months postoperatively]
- Evaluation of Quality of life [Time frame: 0, 6, 12 and 24 months]
- Number of Early onset complication [Time frame: three months postoperatively]
- Number of late-onset complications [Time frame: 6-12-24 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 2 centers
- Mansoura Insurance — Al Mansurah
- Mansoura Oncology — Al Mansurah
Italy · 2 centers
- Ospedale San Raffaele — Milan
- Fondazione Policlinico Universitario Agostino Gemelli — Roma
Argentina · 1 center
- Univesidad de Buenos Aires — Buenos Aires
Greece · 1 center
- National ans Kapodistrian University of Athens — Athens
Poland · 1 center
- University Hospital of Karol Marcinkowski — Zielona Góra
Romania · 1 center
- Prof. Dr. Ion Chiricuta Institute of Oncology — Cluj-Napoca
Spain · 1 center
- Hospital del Mar — Barcelona
Turkey (Türkiye) · 1 center
- Marmara University School of medicine — Istanbul
United Kingdom · 1 center
- University Hospitals of Leicester — Leicester
Publications
- Di Micco R, Scardina L, Botteri E, Banys-Paluchowski M, Cardoso MJ, de Boniface J, Gasparri ML, Gulluoglu BM, Kaidar-Person O, Nava MB, Poortmans P, Potter S, Rocco N, Spanic T, Thill M, Travado L, Veselinovic K, Weber WP, Zuber V, Cisternino G, Baleri S, Rampa M, Corona SP, Calabretto F, Ceccarino R, Rottino A, Franceschini G, Kuhn T, Gentilini OD; I-PREPARE Study Group. Pre-Pectoral Breast Recon PMID 42383235
Identifiers
NCT: NCT05817175 · EUBREAST-11R