International Prospective REgistry on Pre-pectorAl Breast REconstruction

IRCCS San Raffaele1,236 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,236

Conditions

Breast Cancer

Interventions

pre-pectoral breast reconstructionPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Univesidad de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Mansoura Insurance

Al Mansurah, Egypt

RECRUITING

Outcomes

Primary Outcomes

Number of patients with Implant-loss at 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

Time frame: three months postoperatively

Secondary Outcomes

Number of patients with Infection

Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;

Time frame: three months postoperatively

Number of patients with re-admission and re-operation

Rate of re-admission and re-operation

Time frame: three months postoperatively

Evaluation of Quality of life

Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)

Time frame: 0, 6, 12 and 24 months

Number of Early onset complication

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

Time frame: three months postoperatively

Number of late-onset complications

seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;

Time frame: 6-12-24 months

Central Contacts

Oreste D Gentilini, Dr

CONTACT

+390226431 gentilini@eubreast.com

Rosa Di Micco, Dr

CONTACT

+390226431 dimicco.rosa@hsr.it

Data from ClinicalTrials.gov

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