EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIRCCS San Raffaele

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

276 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

Regional Hospital Lugano (EOC), Switzerland

Collaborator