Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Operable Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- One-stage DTI
- description
- Patients who underwent one-stage direct-to-implant pre-pectoral reconstructive strategy
- label
- Two-stage TE-I
- description
- Patients who underwent two-stage expander-implant pre-pectoral reconstructive strategy
Primary outcomes (1)
- measure
- Primary objective
- timeFrame
- 3 months post-surgery
- description
- To evaluate the rate of implant loss within 3 months per patient
Secondary outcomes (1)
- measure
- Secondary objectives
- timeFrame
- 3, 12, 24 months post-surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available