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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

276 Participants
are grouped into 2 trial groups
Group A: One-stage DTI
Group B: Two-stage TE-I

Trial outcomes

Primary outcomes

1

Primary objective

To evaluate the rate of implant loss within 3 months per patient

Time frame
3 months post-surgery

Secondary outcomes

1

Secondary objectives

To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates

Time frame
3, 12, 24 months post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: