Clinical trial · Observational
International Prospective REgistry on Pre-pectorAl Breast REconstruction
NCT05817175CI-TRIAL-00090538I-PREPARErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pre-pectoral breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with Implant-loss at three months postoperatively
- timeFrame
- three months postoperatively
- description
- Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
Secondary outcomes (5)
- measure
- Number of patients with Infection
- timeFrame
- three months postoperatively
- description
- Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
- measure
- Number of patients with re-admission and re-operation
- timeFrame
- three months postoperatively
- description
- Rate of re-admission and re-operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients older than 18 years old * Signed informed consent form * Patients undergoing mono or bilateral therapeutic mastectomy * Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh Exclusion Criteria: * Male patients * Patients not suitable for surgical treatment * Patients undergoing subpectoral reconstruction * Patients undergoing breast reconstruction with autologous tissue.
References
Publications (1)
- DERIVEDDi Micco R, Scardina L, Botteri E, Banys-Paluchowski M, Cardoso MJ, de Boniface J, Gasparri ML, Gulluoglu BM, Kaidar-Person O, Nava MB, Poortmans P, Potter S, Rocco N, Spanic T, Thill M, Travado L, Veselinovic K, Weber WP, Zuber V, Cisternino G, Baleri S, Rampa M, Corona SP, Calabretto F, Ceccarino R, Rottino A, Franceschini G, Kuhn T, Gentilini OD; I-PREPARE Study Group. Pre-Pectoral Breast Reconstruction after Mastectomy: Current Evidence, Knowledge Gaps, and Rationale for the I-PREPARE EUBREAST-11R Trial. Breast Care (Basel). 2026 Jun 5. doi: 10.1159/000551101. Online ahead of print. PMID 42383235