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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Operable Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Primary objective

Time frame: 3 months post-surgery

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

Secondary outcomes

Secondary objectives

Time frame: 3, 12, 24 months post-surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rosa Di Micco, MD, PhD

CONTACT

[email protected]

+39 022643 ext. 4565

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Regional Hospital Lugano (EOC), Switzerland

Registry information

Official study title

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

Acronym: EXPRESSO

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 18, 2026
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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