Clinical trial NCT05817175: International Prospective REgistry on Pre-pectorAl Breast REconstruction
Official title: International Prospective REgistry on Pre-pectorAl Breast REconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast reconstruction
Pre-pectoral Breast Prosthesis
Mastectomy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: EUBREAST ETS
First posted: 2023-04-18
Enrollment: 1236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient.

The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.

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.

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.

Primary outcomes:
measure: Number of patients with Implant-loss at three months postoperatively
timeFrame: three months postoperatively
Secondary outcomes:
measure: Number of patients with Infection
timeFrame: three months postoperatively
measure: Number of patients with re-admission and re-operation
timeFrame: three months postoperatively
measure: Evaluation of Quality of life
timeFrame: 0, 6, 12 and 24 months
measure: Number of Early onset complication
timeFrame: three months postoperatively
measure: Number of late-onset complications
timeFrame: 6-12-24 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Univesidad de Buenos Aires
city: Mansoura
country: Egypt
facility: Mansoura Insurance
city: Mansoura
country: Egypt
facility: Mansoura Oncology
city: Athens
country: Greece
facility: National ans Kapodistrian University of Athens
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: MI
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
city: Zielona Góra
country: Poland
facility: University Hospital of Karol Marcinkowski
city: Cluj-Napoca
country: Romania
facility: Prof. Dr. Ion Chiricuta Institute of Oncology
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Istanbul
country: Turkey
facility: Marmara University School of medicine
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: IRCCS San Raffaele
name: Oreste D Gentilini, Dr
role: STUDY_CHAIR
References: