Evaluating prosthetic breast reconstruction after mastectomy
Prosthetic Breast Reconstruction After Mastectomy: Comparison of Clinical, Anthropometric and Patient Satisfaction Parameters
This study is testing how well two different types of breast reconstruction after mastectomy work for women and how satisfied they are with the results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06774352 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of traditional prosthetic breast reconstruction techniques following mastectomy in women. It focuses on comparing the outcomes of immediate breast reconstruction (DTI) and two-stage reconstruction (EXP-IMPL) in terms of clinical results, anthropometric measurements, and patient satisfaction. By analyzing data collected from patients who have undergone these procedures, the study seeks to determine whether the EXP-IMPL technique remains a viable option or has become outdated. The findings will be statistically analyzed to provide insights into the current state of breast reconstruction options.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 70 who are undergoing mastectomy and are considering prosthetic breast reconstruction.
Not a fit: Patients opting for autologous breast reconstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help validate effective breast reconstruction techniques, improving patient satisfaction and quality of life post-mastectomy.
How similar studies have performed: While similar studies have explored breast reconstruction techniques, this specific observational approach to evaluate the relevance of traditional methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sex F * Patients undergoing mastectomy (R-m, SS-m, NSS-m) * Age 18 - 70 * Prosthetic breast reconstruction (DTI or EXP-IMPL) * Written informed consent Exclusion Criteria: * Autologous breast reconstruction
Where this trial is running
Bologna
- IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Valentina Pinto, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Marco Pignatti, MD
- Email: marco.pignatti@unibo.it
- Phone: +39 051 2143614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.