About this trial
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies:
(i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I).
Each approach is associated with specific indications, advantages, and inherent limitations.
The EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients ≥18 years
Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer
One-stage DTI, or
Two-stage TE-I
Disqualifiers
Male patients
Subpectoral implant-based reconstruction
Autologous breast reconstruction
Delayed reconstructions not performed at the time of mastectomy
Trial population
Data from breast cancer patients who completed pre-pectoral implant-based breast reconstruction, both DTI and TE-I, between January 2022 and December 2024, will be retrospectively extracted from electronic medical records and institutional databases.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary objective
To evaluate the rate of implant loss within 3 months per patient
Secondary outcomes
Secondary objectives
To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates
Locations
Sponsors and contacts
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IRCCS San Raffaele
Lead sponsor
Regional Hospital Lugano (EOC), Switzerland
Collaborator
This trial is not recruiting at the moment. You can still explore other options: