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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07593651

Acronym

EXPRESSO

Enrollment

276

Registered

2026-05-18

Start date

2026-06-01

Completion date

2027-12-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Operable Breast Cancer

Keywords

breast cancer, Mastectomy, Pre-pectoral reconstruction

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients ≥18 years * Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer * Patients undergoing pre-pectoral implant-based breast reconstruction, either: * One-stage DTI, or * Two-stage TE-I * Use of implant with or without biological or synthetic mesh * Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side

Exclusion criteria

* Male patients * Subpectoral implant-based reconstruction * Autologous breast reconstruction * Delayed reconstructions not performed at the time of mastectomy * Incomplete clinical or follow-up data for primary endpoint analysis

Design outcomes

Primary

Measure	Time frame	Description
Primary objective	3 months post-surgery	To evaluate the rate of implant loss within 3 months per patient

Secondary

Measure	Time frame	Description
Secondary objectives	3, 12, 24 months post-surgery	To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates

Contacts

CONTACTRosa Di Micco, MD, PhD

dimicco.rosa@hsr.it+39 022643

Outcome results